Neoplasms

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All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Mouth and Tooth Diseases

Eye Diseases

Rare Diseases

Breast Neoplasms

Thyroid Neoplasms

Thyroid Diseases

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Urologic Neoplasms

Genital Neoplasms, Female

Lip Neoplasms

Eye Neoplasms

Genital Neoplasms, Male

Breast Diseases

Skin Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Diseases, Male

Male Urogenital Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Urologic Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Pembrolizumab

Doxycycline

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Participants receive Pembrolizumab by vein over about 30 minutes on Day 0 and then every 3 weeks for up to 12 months.

Clostridium novyi-NT injected into the tumor on Day 8.

Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT

200 mg by intravenous infusion starting on Day 0, and continuing every 3 weeks for up to 12 months.

Participants given a single dose of Clostridium Novyi-NT by intratumoral injection on Day 8.

Clostridium Novyi-NT administered starting with Cohort 1 at a dose of 3 x 10\^4 spores followed by dose escalation.

Clostridium Novyi-NT

Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT

Sarina Piha-Paul, MD, PHD

Sarina Piha-Paul, MD

Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that areas of the tumor do not have many blood vessels, which makes it difficult for drugs to reach those areas. One way that researchers have recently tried to overcome this problem is by injecting special kinds of bacteria into the tumors. These bacteria have been genetically changed to remove the chemicals that are poisonous to humans, but are still able to cause tumor cells to break down and die. The idea is that these bacteria may be able to assist chemotherapy drugs in fighting cancer.

The goal of this clinical research study is to find the highest tolerable dose of one of these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be studied, as well as whether it can help to control the disease.

This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved for the treatment of melanoma and different types of head and neck and non-small cell lung cancers. It is investigational to use these drugs in combination with each other in various types of advanced cancers.

The study doctor can describe how the study drugs are designed to work.

Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of Clostridium novyi-NT based on when you join this study. Up to 4 dose levels will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of Clostridium novyi-NT. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of Clostridium novyi-NT is found, or all 4 dose levels are filled.

During the study, the supporting company (BioMed Valley Discoveries, Inc.) and study doctors may increase the number of patients in a dose group based on the available study results. This will not change your participation while on study.

All participants will receive the same dose level of pembrolizumab.

Study Drug Administration:

You will receive pembrolizumab by vein over about 30 minutes on Day 0 and then every 3 weeks for up to 12 months.

Clostridium novyi-NT will be injected into the tumor on Day 8. This is the only injection into the tumor you will receive. Your doctors may use an x-ray or ultrasound to help place the needle into the tumor. You will be in the hospital for 7 days to check for side effects, or possibly longer if your study doctor thinks it is needed. You will be able to go home if you have no signs or symptoms of infection. If the study doctor thinks it is needed (for example, based on your tests or any infection symptoms), you may need to return to the hospital at a later time.

Starting on Day 15, you will take an antibiotic (doxycycline) by mouth 2 times a day for the rest of your life to lower the risk of further growth of Clostridium novyi-NT. This is because the study drug is a changed form of bacteria. If you miss a dose or forget to take doxycycline, take it as soon as you can. If it is almost time for your next dose, wait until then to take it and you should skip the missed dose. Do not take an extra dose to make up for a missed dose.

If the doctor thinks it is needed, you will also take additional antibiotics, piperacillin/tazobactam and metronidazole. The antibiotic that is given and the length of time you need to take it will depend on your reaction to the study drug. You should still continue to take doxycycline. Your doctor will discuss this with you. You may receive piperacillin/tazobactam by vein over about 30 minutes and metronidazole by vein over about 30-60 minutes as often as your doctor tells you to, until your doctor thinks it is acceptable for you to change to taking the antibiotics by mouth. In some cases, if you need to receive antibiotics by vein for more than a week or two, your doctor may ask you to have a central venous catheter placed. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

You may also be given other standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Length of Study Participation:

You may receive 1 dose of Clostridium novyi-NT and receive pembrolizumab every 3 weeks for up to 12 months. You will then have 12 months of follow-up after you receive the last dose of pembrolizumab. You will be taken off study early if the disease gets worse, if you have intolerable side effects, or if you are unable to follow study directions.

Your participation on the study will be over after the Month 12 post-dosing follow-up visit.

If you leave the study early, you or your family will be called every 3 months for up to 12 months to see how you are doing. These calls should last less than 30 minutes each time.

Study Visits and Calls:

For your safety, you must stay within 45 minutes driving distance from an emergency room and also have a caregiver available for at least 28 days after you receive your dose of Clostridium novyi-NT spores.

If an abscess (a swollen area of infection that contains pus) forms in the tumor and it needs to be drained, the study doctor may decide to collect some of the drainage for research tests to study the infection and test your immune system response.

Tumor biopsy samples (described below) may be collected at different times than listed, or not at all, depending on the inflammation around the tumor, the amount of tissue available, or how easily it can be collected.

On Days 0 and 1:

* You will have a physical exam.
* You will have an EKG to check your heart function.
* You will have a biopsy sample collected from the target tumor before you receive pembrolizumab. The tumor sample will be used for biomarker testing, including genetic biomarkers and to check your body's inflammatory and immune responses to the study drug. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug. The type of biopsy you have will depend on the location of the disease. The study staff will describe this procedure in more detail, including its risks.
* If you can become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

On Day 8:

* You will have a physical exam.
* Blood (about 4 ½ tablespoons) will be drawn for routine tests, to find out how long the Clostridium novyi-NT spores and bacteria stay in your body, and to measure your risk for bacteremia at 1 hour and 12 hours after the study drug dose.

On Days 9-15 daily:

* You will have a physical exam.
* Blood (about 1½ teaspoons) will be drawn for routine tests.
* You will have either a CT scan or MRI to check the status of the disease (Day 15 only).
* If you have any skin lesions, photographs will be taken of these lesions.

After you leave the hospital and during the first 28 days after you receive Clostridium novyi-NT spores, the study staff will call you 1 time each day on the days you do not have study visits. You will be asked how you are doing. The calls should last less than 30 minutes each time.

On Days 18 and 25, you will have a physical exam.

On Days 21 and 28:

* You will have a physical exam.
* Blood (about 1½ teaspoons) will be drawn for routine tests.

On Days 35:

* You will have a physical exam.
* Blood (about 4 ½ tablespoons) will be drawn for routine tests, to check your body's inflammatory and immune system response to the study drug, to find out how long the Clostridium novyi-NT spores and bacteria stay in your body, and to measure your risk for bacteremia.

At Weeks 6, 9, 15, 24, 39, 45, and 48, you will have a physical exam.

Every 3 weeks beginning with Week 6, blood (about 1 tablespoon) will be drawn for routine testing.

Every 6 weeks beginning with Week 6:

* You will have either a CT scan or MRI to check the status of the disease.
* If you have any skin lesions, photographs will be taken of these lesions.

At Week 9, blood (about 1 teaspoon) will also be drawn for HLA testing.

At Week 12, you will have a tumor tissue biopsy sample collected of the injected tumor and a non-injected tumor for biomarker testing and to help learn how your body is responding to the study drug.

At Weeks 9, 24, 33 and 48, blood (about 4 ½ tablespoons) will be drawn for routine tests, to check your body's inflammatory and immune system response to the study drug, to find out how long the Clostridium novyi-NT spores and bacteria stay in your body, and to measure your risk for bacteremia.

The tests and procedures may be repeated anytime the doctor thinks it is needed.

End of Study Visit:

After you stop receiving the study drug(s):

* Blood (about 3½ tablespoons) will be drawn for routine tests, to check your body's inflammatory and immune system response to the study drug, to find out how long the Clostridium novyi-NT spores and bacteria stay in your body, and to measure your risk for bacteremia.
* You will have either a CT scan or MRI to check the status of the disease.
* If you have any skin lesions, photographs will be taken of these lesions.

Follow Up Visit:

About 30 days after your last dose of pembrolizumab:

* You will have a physical exam.
* Blood (about 1 tablespoon) and urine will be collected for routine tests.
* You will have either a CT scan or MRI to check the status of the disease. It will be repeated every 3 months for up to 12 months.
* If you have any skin lesions, photographs will be taken of these lesions.

After the last follow-up visit, you or a family member will be called every 3 months for an additional year and asked about how you are doing. Each call should last about 15 minutes.

Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT

A Phase Ib Investigation of Pembrolizumab in Combination With Intratumoral Injection of Clostridium Novyi-NT in Patients With Treatment-Refractory Solid Tumors

MTD defined as the highest dose studied in which the incidence of DLT was less than 33%.

BioMed Valley Discoveries, Inc

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Dose Escalation Phase:

Starting dose of Alisertib: 30 mg by mouth 2 times a day on Days 1 - 7 each 21 day cycle.

Starting dose of TAK-228: 1 mg by mouth daily Days 3 - 18, with the exception of 2 mg daily Days 3 - 7 and 10 - 14 schedule in a 21 day cycle.

Dose Expansion Phase:

Alisertib and TAK-228 taken at the maximum tolerated dose from Dose Escalation Phase.

Dose Escalation Phase:

Starting dose of Alisertib: 30 mg by mouth 2 times a day on Days 1 - 7 each 21 day cycle.

Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase.

Alisertib

Dose Escalation Phase:

Starting dose of TAK-228: 1 mg by mouth daily Days 3 - 18, with the exception of 2 mg daily Days 3 - 7 and 10 - 14 schedule in a 21 day cycle.

Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase.

TAK-228

Siqing Fu, MD, PHD

The goal of this clinical research study is to find the highest tolerable dose of the combination of alisertib and TAK-228 that can be given to participants with advanced solid tumors that are associated with HPV. Researchers also want to learn if the study drug combination can help to control advanced solid tumors.

Study Groups:

If participant is found to be eligible to take part in this study, they will be assigned to a dose level based on when they join the study. Up to 5 dose levels of alisertib and TAK-228 will be tested. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of alisertib and TAK-228 is found.

Up to 14 participants will be enrolled onto a Dose Expansion group after the highest tolerable dose combination has been found.

Study Drug Administration:

Each cycle is 21 days.

On Days 1-7 of each cycle, participant will take alisertib by mouth 2 times a day with a glass of water (about 4 ounces).

On Days 3-18 of each cycle, participant will take TAK-228 by mouth 1 time a day Participant should not eat or drink anything for 2 hours before and 1 hour after taking TAK-228.

Study Visits:

Participant will need to take their blood sugar levels every morning while they are on study. Participant will be given a blood sugar monitor and the study staff will show them how to use it. Participant will also have their blood sugar tested in the clinic Participant must fast for at least 8 hours before each of these blood sugar tests. If the doctor thinks it is in participant's best interest, this testing may be decreased to 1 time a week after the first 2 months.

During Week 1 of Cycle 1:

* Participant will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.
* Urine will be collected for routine tests

On Day 1 of Cycles 1 and 2, you will have an EKG.

One (1) time during Weeks 2 and 3 of Cycle 1, blood (about 2 teaspoons) for routine tests and to test participant's blood sugar.

One (1) time a week during Cycles 1 and 2, blood (about 2 teaspoons) will be drawn for routine tests.

During Week 1 of Cycle 2 and beyond:

* Participant will have a physical exam.
* Urine will be collected for routine tests.

During Week 1 of Cycle 3 and beyond, blood (about 4 teaspoons) will be drawn routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.

During Cycles 2, 4, and 6 and then every 3 cycles, participant will have a CT, MRI, or positron emission tomography (PET) scan to check the status of the disease.

Length of Study:

Participant may continue taking the study drugs for as long as they are benefitting. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, if the doctor thinks it is in their best interest, if the study is stopped, if they need treatment that is not allowed on this study, or if they are unable to follow study directions.

Patient's participation on the study will be over after the end-of-study visit.

End of Study Visit:

Within 30 days of participant's last dose of study drugs:

* Participant will have an EKG to check your heart function.
* Participant will have a physical exam.
* Urine will be collected for routine tests.
* Blood (about 3 teaspoons) will be drawn for routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.
* Participant will have a CT, MRI, or PET scan to check the status of the disease.

This is an investigational study. Alisertib and TAK-228 are not FDA approved or commercially available. They are currently being used for research purposes only.

The study doctor can explain how the study drugs are designed to work.

Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.

Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

A Phase I Study of Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

Maximum tolerated dose (MTD) defined by dose limiting toxicities (DLTs) that occur within the initial cycle (21 days).

Clinical benefit categorized by RECIST 1.1.

Millennium Pharmaceuticals, Inc.

Participants take part in the partner-based yoga program.

Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.

Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Participants receive standard of care.

Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

After the study has been completed, participant and caregiver/alternative caregiver offered the opportunity to take part in the partner-based yoga program.

Participants receive yoga sessions up to 5 days per week, based on the patient's schedule, over the course of patients' Radiation Therapy (up to 15 sessions, 45-60 min. each). Yoga sessions audio and video recorded.

Yoga

Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.

Yoga Questionnaire

Symptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Symptom Questionnaires

Kathrin Milbury, MA,PHD

Objectives:

Primary Aim:

Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients undergoing radiotherapy (RT) and their family caregivers.

Secondary Aims:

1. Establish the initial efficacy of the yoga program in patients and their caregivers regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and grip strength).

Caregiver:

If you agree to take part in this study, your demographic information (such as your age, sex, and race) will be recorded at your first visit.

After your first visit, you and the patient will be assigned to 1 of 2 groups. You will either automatically be assigned to Group 1 if you are in the first 10 couples to join the study, or you will be randomly assigned (as in the roll of dice) to Group 1 or Group 2.

This random assignment is done because no one knows if one study group is better, the same, or worse than the other group. You have about an equal chance of being assigned to each group. However, the assignment is also based on other factors such as age and disease status.

If you are in Group 1, you will take part in the partner-based yoga program.

If you are in Group 2, you will not take part in the partner-based yoga program but will complete the same questionnaires as Group 1. After the study has been completed, you and the patient will be offered the opportunity to take part in the partner-based yoga program. This will be offered outside the study and will be offered at no cost to you.

Group 1 - Yoga Sessions and Alternate Caregiver Questionnaire:

If you are in Group 1, you will take part in up to 15 sessions of yoga over the course of the patient's radiation therapy. Each 45- to 60-minute session will be guided by an instructor either face-to-face or by videoconferencing (FaceTime). You should attend each session together as partners.

If you do not have access to a personal handheld device (such as an iPhone or iPad), an iPad will be assigned to you. You will be asked to complete an iPad agreement form and return the iPad on the date that is noted in the agreement. If the device breaks, please tell the study staff right away.

During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of yoga.

The yoga sessions may be audio- and video-recorded. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to review this tape. The audio and video files are digital and will be destroyed after 7 years. If you do not allow the sessions to be audio- or video-recorded, you cannot take part in this study.

At your fifth session, you will be given a DVD and instructions for practicing yoga at home. While the patient is receiving radiation therapy, you will be asked to practice at home 1 time a day either with the patient or alone on the days you do not have a session at the clinic.

During each week of radiation therapy, you will also complete a questionnaire on your feelings about the yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice yoga outside of class and if you think you are benefitting from the yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with the patient.

If you are an alternate caregiver, you will complete a quality-of-life questionnaire at your first yoga session and at the end of the patient's treatment. The questionnaire at the end of treatment can be completed by mail, over the phone with the study staff, or at a clinic session. Completing the questionnaire should take less than 10 minutes.

Groups 1 and 2 - Questionnaires:

You will complete about 12 questionnaires before the patient's first radiation treatment) and again 3 months later. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, health care, work productivity, and quality of life. It should take about 55 minutes to complete these questionnaires.

During the last week of the patient's radiation therapy, you will complete about 8 questionnaires. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, and quality of life. It should take about 45 minutes to complete these questionnaires.

Length of Study:

Your participation on this study will be over when you have completed the last questionnaires.

Patient:

If you agree to take part in this study, your medical history and demographic information (such as your age, sex, and race) will be recorded at your first visit. Additional medical information will be collected from your medical record, such as current/past nicotine use.

If you sign this consent, your caregiver will be approached to take part in this study.

After your first visit, you and your caregiver will be assigned to 1 of 2 groups. You will either automatically be assigned to Group 1 if you are in the first 10 couples to join the study, or you will be randomly assigned (as in the roll of dice) to Group 1 or Group 2.

This random assignment is done because no one knows if one study group is better, the same, or worse than the other group. You have about an equal chance of being assigned to each group. However, the assignment is also based on other factors such as your age and the status of the disease.

If you are in Group 1, you will take part in the partner-based yoga program.

If you are in Group 2, you will not take part in the partner-based yoga program but will complete the same questionnaires as Group 1. After the study has been completed, you and your caregiver/alternative caregiver will be offered the opportunity to take part in the partner-based yoga program.

Group 1 - Yoga Sessions:

If you are in Group 1, you will take part in up to 15 sessions of yoga over the course of radiation therapy. Each 45- to 60-minute session will be guided by an instructor either face-to-face or by videoconferencing (FaceTime). You should attend each session together as partners.

If you do not have access to a personal handheld device (such as an iPhone or iPad), an iPad will be assigned to you. You will be asked to complete an iPad agreement form and return the iPad on the date that is noted in the agreement. If the device breaks, please tell the study staff right away.

During the yoga sessions, you will be asked to do deep-breathing exercises and perform different stretching and movement exercises. The movements are designed not to be difficult, and you will sit on the floor or in a chair while you do them. You can move through the exercises at your own pace. The instructor will be available to answer any questions you may have about the practice of yoga.

The yoga sessions may be audio- and video recorded. This is so the researchers can keep track of the quality of the sessions. Only the study staff will be able to review this tape. The audio and video files are digital and will be destroyed after 7 years. If you do not allow the sessions to be audio- or video-recorded, you cannot take part in this study.

At your fifth session, you will be given a DVD and instructions for practicing yoga at home. While you are receiving radiation therapy, you will be asked to practice at home 1 time a day either with your caregiver or alone on the days you do not have a session at the clinic.

During each week of radiation therapy, you will also complete a questionnaire on your feelings about the yoga sessions. You will be asked to list what you liked or disliked, what you found most and least useful, and how you would rate the instructor. You will also be asked about how often you practice yoga outside of class and if you think you are benefitting from the yoga program. It should take about 5 minutes to answer this questionnaire. Your answers to the questions will not be shared with your caregiver.

Groups 1 and 2 - Questionnaires:

You will complete about 12 questionnaires before your first radiation treatment and again 3 months later The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, health care, work productivity, and quality of life. It should take about 55 minutes to complete these questionnaires.

During your last week of radiation therapy, you will complete about 8 questionnaires. The questionnaires ask about your health, any symptoms you may be having, your mood, fatigue level, sleeping habits, relationship, and quality of life. It should take about 45 minutes to complete these questionnaires.

During Week 3 of radiation therapy and 4 weeks after radiation therapy, you will complete the symptom questionnaire. It should take about 5 minutes to complete. You can complete it over the phone with the study staff or at a clinic session.

Additional Tests for Both Groups:

You will complete a sit-to-stand and grip strength test before your first radiation treatment and once weekly at radiation therapy visits during the time that you receive radiation therapy. The sit-to-stand test measures how easily you sit down and stand up out of a chair. The grip strength test measures the strength of your hands and lower arms. These tests should take about 5 minutes to complete.

Length of Study:

Your participation on this study will be over when you have completed the last questionnaires.

Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

Trial considered feasible if 1) ≥ 50% of eligible couples consent (i.e., approach 80 couples to obtain 40 consents); 2) ≥ 70% of enrolled couples complete both assessments; 3) on average ≥ 50% of all practice sessions are attended.

Efficacy of the yoga program determined by responses on quality of life (QOL) questionnaires.

Digestive System Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Deglutition Disorders

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned with MRI guidance. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-strobe procedure performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

IMRT planned by standard-of-care. Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Modified Barium Swallow (MBS)

Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Swallowing Questionnaire

Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Symptom Questionnaire

Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.

Video-Strobe Procedure

MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning

Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning

Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.

Intensity Modulated Radiotherapy (IMRT)

Clifton Fuller, MD, PHD

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.

This is an investigational study. MRI simulations and radiation therapy are delivered using FDA-approved and commercially available methods. The use of MRI imaging to plan the dose is investigational.

Up to 90 participants will be enrolled in this study. All will take part at MD Anderson.

Baseline Visit:

If you are found to be eligible to take part in this study and agree, you will have a baseline visit. The following tests and procedures will be performed:

* You will have a hearing test.
* You will have a dental exam. During this exam, your saliva flow will be measured and you will be checked for lockjaw.
* Your swallowing function will be tested with a special type of x-ray called a modified barium swallow (MBS). During the test, you will eat and drink foods and liquids mixed with a "contrast" chemical called barium that will make your throat more visible in the x-rays. A special x-ray tube will be connected to a television screen to allow the doctor to watch the foods and liquids pass from your mouth and down your throat.
* You will complete a questionnaire about swallowing that should take about 5 minutes to complete.
* You will have a video-strobe procedure to check your vocal cords. To perform a video-strobe procedure, a small camera will be inserted into the throat through your nose or mouth. You will be awake for this procedure and the study staff will give you the option of receiving a numbing spray for your nose and/or throat.
* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will fill out questionnaires about your quality of life, work status, medical history, smoking status, and any symptoms you may have. Completing these questionnaires should take about 10-15 minutes.

Study Groups:

If you are among the first 15 patients enrolled in the study, you will be in Group 1.

If you join the study after the first 15 patients have enrolled, you will be randomly assigned (as a flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If you are in Group 1, an MRI will be used to plan your IMRT.
* If you are in Group 2, you will receive standard-of-care IMRT.

Length of Study Participation:

No matter which group you are in, you may continue receiving radiation therapy for up to 6 ½ weeks. You will no longer be able to take part in this study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your overall participation on the study will be over after 5 years.

Treatment Planning and Schedule:

You will receive a standard CT simulation which will cover your head and neck for treatment planning. You will also have a PET-CT to check the status of the disease and for treatment planning purposes.

If you are among the first 15 participants or are in Group 1, you also will have an MRI simulation for treatment planning purposes.

All groups will then receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).

Study Visits:

Every week while you are receiving radiation therapy:

* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests.
* You will fill out the same questionnaires as before.
* You will have an MRI.

At Weeks 3 and 6:

* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will have a dental exam.

If you are among the first 15 participants or are in Group 1, you will also have the MRI simulation at the end of Weeks 1, 2, 3, and 4 of treatment.

Six (6) weeks after finishing radiation therapy, you will complete the same questionnaires as before.

Within 8-12 weeks after finishing radiation therapy:

* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will have a hearing test.
* If you are among the first 15 participants or are in Group 1, you will have an MRI simulation.

Six (6) months, 1 year, and 2 years after finishing radiation therapy:

* You will fill out the same questionnaires as before.
* You will have a mouth exam to check your swallowing function.
* Photos of the inside of your mouth will be taken to check for mouth sores.
* You will fill out the same questionnaires as before.
* You will have a video-strobe procedure to check your vocal cords.
* At 1 year only, you will have a dental exam and an MBS exam to test your swallowing function.
* At 1 year and 2 years only, you will also have a hearing test.

Three to six (3-6) months, 1 year, and 18-24 months after finishing radiation therapy:

* You will have an MBS exam to test your swallowing function.
* You will fill out the same questionnaires as before.
* You will have the video-strobe procedure to check your vocal cords.

Two (2) years after finishing radiation therapy and if the disease gets worse, blood (about 3 teaspoons) will be drawn for circulating tumor cells (CTCs). This is a test of how many tumor cells are in the blood.

Five (5) years after finishing radiation therapy, you will have an MBS exam to test your swallowing function and will complete the same questionnaires as before.

If the doctor thinks it is needed during follow-up, you will have a tumor biopsy for tumor marker testing and a CT scan, MRI scan and/or PET/CT scan to check the status of the disease.

Follow-Up Calls:

During the 8-12 weeks while you are recovering from treatment, you will be called or emailed by an automated system every 2 weeks.

This will be to remind you to fill out a web-based form that asks about any side effects you may have had. Completing the form should take about 10-15 minutes each time.

Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Bayesian Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer

Relapse defined as reappearance of tumor after complete response. If possible, relapse confirmed by biopsy.

Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

These include: 1) PEG tube dependence at last follow-up; 2) trace or frank aspiration seen on modified barium swallow study; 3) diagnosis of aspiration pneumonia; 4) presence of pharyngoesophageal structure on modified barium swallow study or endoscopy with subsequent need for dilation.

Composite dysphagia outcome calculated based on objective measurements of severe dysphagia.

Overall survival, calculated as time from diagnosis to either death or last follow-up, with death serving as an event and all others censored.

Progression-free survival, calculated as time from diagnosis to either death or detection of recurrent disease after an interval without radiographic of clinically evident disease (whichever is earlier), with death or recurrence detection serving as an event and all others censored.

Distant metastasis-free survival, calculated as time from diagnosis to either death or detection of disease outside of the head and neck after an interval without radiographic of clinically evident disease (whichever is earlier), with death or metastasis detection serving as an event and all others censored.

Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI)

Physician-reported toxicity, defined as any grade 3-4 adverse events using Common Terminology Criteria for Adverse Events (CTCAE)-4.0.

National Cancer Institute (NCI)

Musculoskeletal Diseases

Melanoma

Skin Neoplasms

Osteosarcoma

Bone Neoplasms

Neoplastic Processes

Bone Diseases

Pharmaceutical Solutions

Gemcitabine

Antimetabolites

Dose Escalation Cohort: Participants take Gemcitabine by mist 2 times each week for 4 weeks (28 days).

Expansion Cohort: Participants with OS lung metastases receive study drug at the maximum tolerated dose from Dose Escalation Cohort.

Participants may continue to receive the study drug for up to 12 cycles per decision of doctor.

Nebulized dose of aerosol GCB twice a week continuously (escalating treatment dose schema, starting at 0.75 mg/kg to 3.0 mg/kg). Participants receive a pre-determined volume of nebulized solution, according to the dose level and weight of the participant, with each aerosol GCB administration. One cycle is 4 weeks in duration.

Najat C. Daw-Bitar, MD

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.

The safety and side effects of this drug will also be studied.

This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work.

Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of gemcitabine based on when you join this study. Up to 6 dose levels of gemcitabine will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects are seen. This will continue until the highest tolerable dose of gemcitabine is found.

Each study cycle is 28 days. You will take gemcitabine by mist 2 times each week for 4 weeks (28 days). Treatment will be administered at MD Anderson. A machine called a nebulizer will be used to make the gemcitabine mist. The study staff will provide you with protective materials and instructions on how to take the treatment. You will breathe the drug mist through the mouthpiece of the nebulizer. The study staff will tell you which days you will receive the study drug. If the doctor thinks it is in your best interest, you may continue to receive the study drug for up to 12 cycles.

Length of Study:

You may continue taking the study drug for up to 12 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If you have developed a tumor outside of the lungs either before or while you are on study, and the doctor thinks it is in your best interest, you may have a local control procedure (such as radiation or surgery) that may help to control the disease while continuing to receive the study drug. You would sign a separate consent form explaining these procedures and their risks. If you and your doctor decide on a systemic cancer treatment by mouth or vein, you will no longer be able to receive treatment on this study. A systemic cancer treatment is designed to spread and treat cancer cells throughout the body.

Your participation on the study will be over after your last follow-up phone call.

Study Visits:

Within 3 days before Day 1 of every cycle:

* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests and to check your liver function.
* You will have PFTs.
* You will have your blood oxygen level measured by pulse oximeter.
* If you can become pregnant, urine will be collected for a pregnancy test.

On Day 8 of Cycle 1:

* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests and to check your liver function.

You will have a CT scan at the end of Cycles 2, 4, and 6, and then every 3 cycles after that. The study doctor will tell you when you will have these scans. If you have a chest X-ray, MRI, and PET scan as part of standard of care while you are on study, the study doctor may use the results to check the status of the disease.

To avoid having to come to the study clinic too often, you may have blood draws done by your personal doctor.

You may be called by the study staff and asked about how you are doing and about any side effects about 1 day after your first 2 doses of the study drug, at the end of Cycle 1, and 1 time every 3 months after that until you leave the study or the study ends. These calls should last about 15-20 minutes each time.

Other Information:

Each day that you take study drug:

* You will write down the date and the day of the study cycle in a dosing diary given to you by the study staff. You should bring the diary to all clinic visits.
* You will be given a pulse oximeter to measure your heart rate and blood oxygen level. °You should record your results in the dosing diary.
* You will use a small hand-held device to test your lung function before the dose and answer questions about side effects you may be having.

You will also be given an electronic device (such as a laptop or tablet) so that you can upload the information from the lung function tests and send it to the study doctor. You will only be able to access study specific material on this device. The study staff will show you how to use all of the provided machines. If the device is lost, stolen, or damaged, you will need to immediately report it to the study staff and you will be responsible for its replacement.

You should bring the nebulizer with you to all study visits.

You will be asked to return the nebulizer, pulse oximeter, lung function device, and electronic device when your participation on this study is over.

End of Dosing Visit:

Within 30 days of your last dose of the study drug:

* You will have a physical exam.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* You will have PFTs.
* You will have your blood oxygen level measured by pulse oximeter.
* You will have a CT scan.

Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

MTD is defined as highest dose level with six patients with at most 1 dose limiting toxicity (DLT) occurring during cycle 1. Dose levels will continue to be increased until 1 participant experiences DLT. If only 1 of 3 participants experiences DLT, 3 additional patients will be entered.

Dose escalation conducted via accelerated titration method for first 2 dose levels followed by 3+3 method for remaining dose levels. Cohorts of 1 participant per dose level for first 2 dose levels. If at any time during cycle 1 there is an instance of pulmonary grade 2 toxicity or pulmonary function tests (PFT) decline\>10% related to study drug, current dose level expanded to 3 participants \& switched to 3+3 design. If neither of these nor any other DLT occur in dose levels 1-2, switch will be to the 3 + 3 design beginning with dose level 3. Three participants will be treated at dose level 3, if still no DLT, 3 more treated at dose level 4.

Dose limiting toxicities associated with the MTD of aerosol GCB using the NCI Common Terminology Criteria version 4 for Adverse Events (CTCAE) will be utilized for AE reporting. DLT defined as any of the following events that are at least (possibly, probably or definitely) attributable to aerosol GCB. The observation period for the purposes of dose-escalation will be the first cycle of therapy.

DLT Definition includes:

* Any episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity.
* or \> 10% decrease in FEV1 that persists \> 3 days after the drug is stopped or recurrent episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity.
* Any grade 3 or 4 non-hematological toxicity.
* Any grade 4 neutropenia or thrombocytopenia.

Assessment of serum levels of Gemcitabine (GCB) for evidence of spillover into the circulation and correlate with presence or absence of toxicity.

Response evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

James B. and Lois R. Archer Charitable Foundation

Gateway for Cancer Research

Utomilumab by vein every 4 weeks for up to 12 doses beginning on Cycle 1 Day 1.

ISA101b as an injection under the skin every 4 weeks for 3 doses. Participants receive 2 injections each time.

Utomilumab given by vein on Cycle 1 Day 1. Cycle 1-2 100 mg, Cycle 3-12 50 mg until progressive disease, toxicity, or 1 yr.

Utomilumab

ISA101b 100 mcg/peptide given subcutaneously every 4 weeks x 3 doses beginning cycle 1 day 1.

ISA101b

Bonnie S. Glisson, BS,MD

The goal of this clinical research study is to learn if utomilumab, when given with ISA101b, is able to shrink or slow the growth of tumors in patients with incurable HPV+ oropharyngeal squamous cell carcinoma.

This is an investigational study. Utomilumab and ISA101b are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work.

Up to 27 participants will be enrolled. All will take part at MD Anderson.

Study Drug Administration:

There are 28 days in each study cycle.

You will receive utomilumab by vein every 4 weeks for up to 12 doses beginning on Cycle 1 Day 1. The drug will be given over about 1 hour each time you receive it.

You will receive ISA101b as an injection under the skin every 4 weeks for 3 doses. You will receive 2 injections each time. One may be in your arm and one in your leg.

Length of Study:

You may continue taking utomilumab for up to 1 year as long as your doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if intolerable side effects occur or if you are unable to follow study directions. You may not be able to take the study drug(s) if the disease gets worse, which is explained below.

Your participation on the study will be over after the follow-up visits.

Study Visits:

On Day 1 of Cycles 1-12:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.
* If you can become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.
* During Cycles 1, 2, 3, 4, 8, and 12, blood (up to 10 tablespoons) will be drawn for biomarker testing (including genetic biomarkers).

At the end of Cycle 2 and every 8 weeks after that, you will have an MRI or CT scan to check the status of the disease.

Study Continuation:

If the disease appears to have gotten worse, you may still be eligible to continue receiving your assigned study drug(s). This is because you may be benefitting from the study drug(s) even though the tumor(s) got larger. Your doctor will discuss this with you.

If this happens, your doctor will talk to you about whether or not you want to continue. If you do continue taking part in the study, you will follow the study visits as described above.

However, there are risks of continuing to receive the study drug(s) because the disease may actually be getting worse. You are still at risk for side effects due to utomilumab and ISA101b. Continuing on this study could also delay starting other treatments. The disease may get worse to the point that you are no longer able to receive other treatments. There are also risks from the additional tests that may be performed, such as biopsies and blood draws. You and your doctor will discuss these possible risks, and you will be asked to decide if you want to continue receiving the study drug(s).

End-of-Treatment and Follow-up Visits:

At about 30 days after your last study drug dose:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.
* If you are able to become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

At about 70 days after your last study drug dose:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be collected for routine tests, thyroid function tests, and liver function tests.
* If you are able to become pregnant, blood (about ½ teaspoon) or urine will be collected for a pregnancy test.

You will also be called every 3 months up to 1½ years and asked about your health. Each call should last about 10-15 minutes.

If you stopped taking the study drug for reasons other than the disease getting worse, you will continue to have MRI/CT scans every 8 weeks. If the disease appears to get worse, or you start a new anticancer therapy, these scans will stop.

Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

Phase II Trial of Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer

Overall Response Rate assessed by RECIST 1.1 Criteria

Adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for grades 1-3.

Response rate monitored by radiographic assessment.

PFS defined as the time from first day of treatment to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause.

ISA Pharmaceuticals B.V.

Pfizer

Treatment with Utomilumab every 4 weeks and 3 doses of ISA101b Vaccination for every 4 weeks first 3 cycles in Patients with HPV-16-Positive Incurable Oropharynx Cancer

Utomilumab and ISA101b

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who signed the consent are included in the baseline characteristics.

Dr. John Heymach, PHD-Chair, Thoracic-Head & Neck Med Onc

Overall Response Rate (ORR) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Grade 1

Grade 2

Grade 3

Adverse Events of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

No data collected for Response Rate by irRC of Utomilumab Combined with ISA 101b in Patients with Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Response Rate by irRC of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Progression Free Survival (PFS) of Utomilumab Combined With ISA 101b in Patients With Incurable Human Papillomavirus - Positive (HPV+) Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT	NCT03435952	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl...	Pembrolizumab Clostridium Nov... Doxycycline	18 Years -	M.D. Anderson Cancer Center
Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies	NCT02812056	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl...	Alisertib TAK-228	18 Years -	M.D. Anderson Cancer Center
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center
Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaptation in Human Papilloma Virus Positive Oropharyngeal Cancer	NCT03224000	Malignant Neopl... Oropharyngeal C...	Modified Barium... Swallowing Ques... Symptom Questio... Video-Strobe Pr... MRI Guided Inte... Standard-of-Car... Intensity Modul...	18 Years -	M.D. Anderson Cancer Center
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases	NCT03093909	Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Malignant Neopl... Melanoma and Ot...	Gemcitabine	12 Years - 50 Years	M.D. Anderson Cancer Center
Utomilumab and ISA101b Vaccination in Patients With HPV-16-Positive Incurable Oropharyngeal Cancer	NCT03258008	Malignant Neopl... Malignant Neopl... Oropharyngeal C...	Utomilumab ISA101b	18 Years -	M.D. Anderson Cancer Center
Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers	NCT03114501	Malignant Neopl... Head and Neck C...	Yoga Yoga Questionna... Symptom Questio...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for malignant neoplasms of lip oral cavity and pharynx