Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Neoplasm Metastasis

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Anti-Infective Agents

All Drugs and Chemicals

Minocycline

Anti-Bacterial Agents

Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

100 mg by mouth two times a day (200 mg/day).

Matching placebo capsules by mouth twice a day.

Placebo

Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Questionnaires

David Fogelman, MD

Shelley Wang, MD,MPH

The goal of this clinical research study is to learn if minocycline can reduce the side effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will be compared to a placebo.

Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.

A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:

* If you are in Group 1, you will take minocycline.
* If you are in Group 2, you will take a placebo.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

Each study cycle is about 2 weeks.

You will begin taking the study drug/placebo on, or within 2 days of, Day 1 of the first chemotherapy cycle after you are enrolled on the study. You will take the study drug/placebo capsule by mouth, every day for up to 4 cycles (up to 8 weeks, if there are no treatment delays).

It is possible that your chemotherapy start may be delayed if it takes additional time for your central venous catheter (CVC) to be placed. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. If this happens, you may choose to start taking the study drug/placebo up to 2 weeks before you start chemotherapy, instead of waiting to start taking it on the same day your chemotherapy begins. You can discuss these options with the study doctor.

You should take the study drug/placebo dissolved in a full glass (8 ounces) of water. You may take it with or without food, but if it causes an upset stomach, you should take it with food.

If you have trouble swallowing the dose of study drug/placebo, you can open the capsule right before you take it. You should not lie down for at least 30 minutes after taking the study drug/placebo to reduce the risk of side effects.

You must bring the study drug/placebo container (along with any remaining drug/placebo) to every study visit.

Study Visits:

Before you start your treatment with the study drug/placebo:

* If you can become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test. If the pregnancy test is positive, it will be repeated after 48 hours to make sure you are pregnant. Sometimes, cancer can cause a "false positive" on a pregnancy test.
* You will complete 2 questionnaires about pain and other symptoms, and your quality of life. It should take about 5-8 minutes to complete all of the questionnaires.
* If possible, blood (about 2 tablespoons) will be drawn to test for markers of inflammation. Markers of inflammation are found in the blood and may be related to your symptom development.
* Your demographic information, such as your marital status, job status, education, and race will be recorded.

Before you start your chemotherapy treatment:

°If possible, blood (about 2 teaspoons) may be drawn to test for markers of inflammation, only if you started treatment with the study drug/placebo while you waited for your CVC to be placed for chemotherapy. If you choose to wait to start the study drug/placebo until chemotherapy begins, this blood sample will not be drawn.

During treatment with the study drug/placebo:

* You will complete the symptom questionnaire 2 times each week during the first cycle and 1 time each week during any remaining cycles. The symptom questionnaire asks about any symptoms you may be having and how they may be affecting your daily activities. You will also complete the quality of life questionnaire. The questionnaires should take about 3-5 minutes to complete each time.
* You will complete the questionnaires in paper-and-pencil format or on an electronic tablet PC if you are in the clinic. When you are away from the clinic you will complete the questionnaires on the telephone or on your computer.
* If possible, during your clinic visits at the start of cycle 2, 3, and 4 (if applicable), blood (about 2 tablespoons) may be drawn to test for markers of inflammation.

At the end of study drug/placebo treatment:

When you have finished taking the study drug/placebo, the study staff will contact you to complete a questionnaire asking you about your opinions of the study drug/placebo. This questionnaire will take about 3-5 minutes to complete.

Length of Study Participation:

You will be on study for up to 8 weeks, if there is no delay in starting your chemotherapy cycles. You will take the study drug/placebo for up to 8 weeks. You will be taken off study early if the disease gets worse, you have intolerable side effects, if you are unable to follow study directions, or the study doctor thinks it is in your best interest.

End-of-Study Visit:

At the end of the last study cycle after you complete the symptom treatment, you will complete questionnaires about pain and other symptoms and your quality of life. It should take about 3-5 minutes to complete the questionnaires. If possible, blood (about 2 tablespoons) may be drawn to test for markers of inflammation.

Follow-Up:

The study staff will call you 30 days after you finish taking the study drug/placebo to ask about any side effects you may be having. This call should last about 5 minutes.

This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Using minocycline to try to reduce the side effects of chemotherapy in patients with pancreatic cancer is investigational.

Up to 76 patients will take part in this study. All will be enrolled at MD Anderson.

Minocycline Study in Pancreatic Cancer Patients

A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients

Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.

Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Minocycline: 100 mg by mouth two times a day (200 mg/day).

Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Placebo: Matching placebo capsules by mouth twice a day.

Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Observational

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. David Fogelman/ Associate Professor, GI Medical Oncology

Of the 44 randomized patients, 30 (68% were evaluable for the primary efficacy analysis).

Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms

The blood sample collection was an optional procedure for the participants data were not collected.

Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Lenalidomide

Minocycline 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance chemotherapy for MM.

Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Placebo 200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).

Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance therapy for MM.

200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).

Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Robert Orlowski, MD, PHD

The goal of this clinical research study is to learn if minocycline can help reduce the symptoms reported by patients with MM who receive therapy with lenalidomide.

Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine production, which may help to reduce multiple symptoms.

Study Groups:

If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

Group 1 will take a placebo during maintenance therapy.

Group 2 will take minocycline during maintenance therapy.

A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what they are receiving.

Study Drug Administration:

Participant will take the study drug/placebo by mouth, two times a day for about 3 months, starting the first day (or within 2 days) that they begin their lenalidomide therapy.

Participant should take the study drug/placebo with a full glass (8 ounces) of water. Participant may take it with or without food, but if the study drug/placebo causes an upset stomach, participant should take it with food.

Study Visits:

Participant must bring the study drug/placebo container, along with any remaining drug, with them to their clinic visit at each new cycle of lenalidomide therapy, or at the clinic visit when the study is over if no clinic visits are scheduled until then.

Before participant starts lenalidomide therapy:

* Participant will fill out 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires.
* A study staff member will ask participant questions about their demographic information, such as their marital status, job status, education, and race.
* Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick. Biomarkers are found in the blood/tissue and may be related to participant's reaction to the study drug. Researchers want to study how changes in the biomarkers may be related to the symptoms reported by participants in this study.

During lenalidomide therapy:

°Participant will complete a symptom questionnaire in the clinic or by telephone 1 time each week about any symptoms they may be having and how they may be affecting participant's daily activities. The symptom questionnaire should take about 3-5 minutes to complete each time.

During participant's clinic visit at each new cycle of lenalidomide therapy:

* Participant will fill out 3 questionnaires about their pain and other symptoms. It should take about 15-20 minutes to complete all of the questionnaires each time. If no clinic visit is scheduled until the study is over, these questionnaires will be collected over the phone by the study coordinator.
* Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick.

End-of-Treatment Visit:

Participant will have an end-of-treatment visit at the end of month 3. At this visit, participant will complete 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires. Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick.

Length of Study:

Participant may continue taking the study drug/placebo for up to 3 months. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if they are unable to follow study directions, or the study doctor thinks it is in their best interest.

This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The use of minocycline to reduce chemotherapy related side effects in patients with MM is currently being used for research purposes only.

Up to 88 participants will take part in this study. All will be enrolled at MD Anderson Cancer Center.

Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma

Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.

Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)

Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)

Age, Continuous

Dr. Robert Orlowski, Professor, Lymphoma-Myeloma

Symptom Reduction

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Central Nervous System Stimulants

Modafinil

Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Armodafinil

1 capsule by mouth 2 times a day for 6 weeks.

100 mg by mouth 2 times a day for 6 weeks.

Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

Steven H. Lin, MD, PHD

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness).

Armodafinil is designed to prevent excessive sleepiness.

Minocycline is an antibiotic, which may help to reduce multiple symptoms.

In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If you are eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups. You will have an equal chance of being in any group.

* Group 1 will take armodafinil and a placebo.
* Group 2 will take minocycline and a placebo.
* Group 3 will take armodafinil and minocycline.
* Group 4 will take 2 placebos.

Neither you nor the study staff you will see in the clinic will know if you are receiving the study drug(s) and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.

If needed, you will be given 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.

Study Drug/Placebo Administration:

You will take the study drug/placebo 2 times a day for 6 weeks. You should take the capsules with a full glass of water. If you get an upset stomach, take them with food.

You will be given pamphlets with more information about how to take the study capsules.

You should bring your study capsules to every study visit.

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete a questionnaire about your symptoms. This questionnaire will ask about symptoms from therapy you may be having and how they may be interfering with your daily activities. The study staff will either meet you during your regular clinic visit or call you at your home at a time that is convenient for you. In the clinic, you will complete the questionnaire by paper and pen, or by entering your answers into an electronic tablet computer. On the phone, a study staff member will ask you the questions and record your answers. You will complete the symptom questionnaire before you begin chemoradiation and then 1 time a week for the rest of the study. The symptom questionnaire will take up to 5 minutes to complete.

Study Visits:

Before you begin chemoradiation:

* You will complete questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 5 questionnaires will take about 15 minutes.
* If you can become pregnant and you did not have a pregnancy test during screening, you will have a urine pregnancy test. The study staff will give you the urine pregnancy test kit at your scheduled visit, and will review the results before you pick up the study capsules from the pharmacy.

About Week 3 or 4, you will be asked to complete a questionnaire that asks you about your satisfaction with the study capsules. This will take a few minutes.

During the last week of chemoradiation (about Week 5 or 6):

* You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.
* You will also be asked to complete a questionnaire that asks about your satisfaction with the study capsules. This will take a few minutes.

After about Week 5 or 6, the study staff will call you 1 time a week to check on you until the study ends. This phone call should last only a few minutes. If you have had several side effects from chemoradiation, this phone call may take longer.

At your first routine clinical follow-up visit (about Week 10 to 14):

* You will complete the 3 questionnaires about your symptoms, mood, and quality of life.
* You will also be asked to complete another questionnaire that asks about your satisfaction with the study capsules.

Length of Study:

You will be on study for about 10-14 weeks. You will take the study drug(s) for 6 weeks and complete the symptom survey until the end of the study. You will be taken off study early if you have intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of sleepiness. Minocycline is FDA approved and commercially available for the treatment of bacterial infections. The use of these drugs to help reduce chemoradiation symptoms is investigational.

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

Armodafinil 150 mg once a day during the entire course of chemoXRT (6 weeks + 5 days) or a total of 6 weeks.

Minocycline 100 mg twice a day during the entire course of chemoXT ( 6 weeks + 5 days)

Armodafinil+Minocycline

Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days)

Armodafinil + Placebo

Minocycline 100mg twice a day during the entire course of radiation therapy (6 weeks + 5 days)

Minocycline + Placebo

Armodafinil (150 mg once a day for 6 weeks) + Minocycline (100 mg twice a day for 6 weeks).

Armodafinil + Minocycline

Lin,Steven H,M.D. Ph.D. / Radiation Oncology

Armodafinil (150mg once a day) + Minocycline (100mg once a day)

Placebos

Of the 21 randomized patients , 19 (90% were evaluable for the primary efficacy analysis).

Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.

Armodafinil 150mg once a day during the entire course of radiation (6 weeks + 5 days).

Nervous System Diseases

Peripheral Nervous System Diseases

Pain

Hypesthesia

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Acute Graft Versus Host Disease

Group 2 receives minocycline 200 mg orally for the first dose, then 100 mg orally every 12 hours for 4 months beginning at chemotherapy initiation. Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit. Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

Group 1 receives a placebo 200 mg orally for the first day of chemotherapy, then 100 mg doses every 12 hours for 4 months beginning at chemotherapy initiation. Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit. Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.

1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.

Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit.

Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

Sensory Test

Cathy Eng, MD, BA

The goal of this clinical research study is to learn if minocycline can reduce numbness, pain, and/or loss of motor function in patients with colorectal cancer. In this study, minocycline will be compared to a placebo.

The study doctor can explain how the study drug is designed to work.

A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Nearly 40% of patients with colorectal cancer who receive oxaliplatin-based chemotherapy experience neuropathy (nerve damage that can include numbness, pain, and/or loss of motor function). Sometimes, this nerve damage is serious enough that the chemotherapy dose has to be lowered or stopped completely. Researchers want to find out if taking minocycline can lower the side effects caused by chemotherapy given to treat colorectal cancer.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:

* If you are in Group 1, you will take a placebo.
* If you are in Group 2, you will take minocycline.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

Starting on Day 1 of Cycle 1 of chemotherapy, you will start taking the study drug/placebo capsule by mouth, twice a day every day.

You should take the study drug/placebo with a full glass (8 ounces) of water. You may take it with or without food, but if it causes an upset stomach, you should take it with food.

You should not lie down for at least 30 minutes after taking the study drug/placebo to reduce the risk of side effects.

Study Visits:

Before you start taking the study drug/placebo:

* You will complete 4 questionnaires about pain and other symptoms, and your quality of life. You will also complete a questionnaire about your tobacco history. It should take about 15-25 minutes to complete all questionnaires.
* You may complete a sensory test. For this test, researchers will try to find out how sensitive you are to touching things such as small bumps on a board. This test will take about 10 minutes to complete.
* If possible, blood (about 6 teaspoons) will be drawn to test for markers of inflammation. Markers of inflammation are found in the blood and may be related to your symptoms.

  1 time each week:
* You will complete a questionnaire in the clinic or by telephone about any symptoms you may be having and how they may be affecting your daily activities. The questionnaire should take about 3-5 minutes to complete each time.

At each chemotherapy cycle:

* You will fill out 2 questionnaires in the clinic or by telephone about pain and other symptoms. It should take about 10-15 minutes to complete the questionnaires.
* The study staff will make a count of the number of pills that you took so far. If you are coming to the MD Anderson or Harris Health clinic, bring the study drug/placebo container (along with any remaining drug/placebo).

At about 2 months:

* If you return to the MD Anderson or Harris Health clinic for this visit, the following additional procedures will be performed:
* If possible, blood (about 6 teaspoons) will be drawn to test for markers of inflammation.

You may complete a sensory test. This test will take about 10 minutes to complete.

End-of-Treatment Visit (at about 4 months):

* You will fill out the 4 questionnaires in the clinic or by telephone about your symptoms. It should take about 15-20 minutes to complete all of the questionnaires.
* The study staff will make a count of the number of pills that you took so far.

If you return to the MD Anderson or Harris Health clinic for this visit:

* If possible, blood (about 6 teaspoons) will be drawn to test for markers of inflammation.
* You may complete a sensory test. This test will take about 10 minutes to complete.
* You must bring the study drug/placebo container (along with any remaining drug/placebo).

Length of Study:

You may continue taking the study drug/placebo for up to 4 months, if there are no treatment delays. 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.

Your participation in the study will be over at the End-of-Study visit.

End-of-Study Visit:

At about 6 months, the following tests and procedures will be performed:

°You will fill out 4 questionnaires in the clinic or by telephone about pain and other symptoms and your quality of life. You will also complete a questionnaire about your tobacco history. It should take about 15-25 minutes to complete all of the questionnaires.

If you return to the MD Anderson or Harris Health clinic for this visit:

* If possible, blood (about 6 teaspoons) will be drawn to test for markers of inflammation.
* You may complete a sensory test. This test will take about 10 minutes to complete.

This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Its use in this study is investigational.

Up to 166 participants will be enrolled in this study. Up to 83 will be enrolled at the Harris Health System.

Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients

Phase II, Randomized, Placebo-Controlled Study of Minocycline for Reducing Symptom Burden in Patients With Colorectal Cancer

AUC for MDASI-numbness/tingling . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.

AUC for MDASI-fatigue . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.

American Cancer Society, Inc.

Minocycline 100 mg twice a day during 4 months

Placebo 100 mg twice a day during 4 months

Dr. James Yao, MD, Director of GI Medical Oncology

Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months

Average Area Under the Curve (AUC) for Fatigue Over 4 Months

Thalidomide

Bortezomib

1 dose on first day of induction therapy, then every 12 hours for 10 weeks.

200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks.

One pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.

200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.

Sheeba K. Thomas, MD

The goal of this clinical research study is to see if Minocin® (minocycline) can help to control nerve damage that causes numbness and tingling in the hands and feet (neuropathy) in patients receiving thalidomide and/or bortezomib.

Neuropathy is one of the side effects that occurs in some patients who receive thalidomide and/or bortezomib. Usually it is mild and sometimes improves or goes away when the thalidomide or bortezomib treatment is stopped. However, in some patients, the numbness and tingling remains even after the treatment is stopped. It can make it difficult for patients to feel objects with their hands, or to feel the ground under their feet. This can lead to difficulty with tasks such as buttoning clothes or writing, as well as difficulty walking.

Minocycline is designed to help prevent inflammation of the nerves, which can stop the nerve cells from dying.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Participants in the 2 groups will receive standard education from the study staff about the signs and symptoms of neuropathy. If you are assigned to Group A, you will take a placebo (pills that look like the study drug but do not contain any active ingredients) once on Day 1. Staring on Day 2, you will take the pills 2 times a day (every 12 hours), for 10 weeks. If you are assigned to Group B you will take a larger dose of minocycline 1 time by mouth on the day you start therapy on this study, and then a smaller dose of minocycline by mouth every 12 hours for 10 weeks. Minocycline can be taken with or without food, but it needs to be taken with liquid. No matter which group you are assigned to, you will receive thalidomide and/or bortezomib according to the standard schedule. Neither you nor your doctor nor any of the clinic or research staff will know which medication (placebo or minocycline) you are receiving. Only the pharmacist who gives you the medication will know. If there is any serious concern for your safety because of the medication you might be receiving, your doctor will be told which medication you are receiving.

Study Visits:

One (1) time a week during Weeks 1-9, you will complete the symptom questionnaire. This questionnaire may be done in person or by phone.

Before you begin each new cycle of multiple myeloma therapy for 10 weeks, the following tests and procedures will be performed:

* You will have a physical exam.
* Your complete medical history will be recorded, and you will be asked about any drugs you may be taking.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.
* Blood (about 4 teaspoons) will be drawn to test for certain cytokines.
* You will have a nerve function test.
* You will complete the questionnaire that has questions about unusual sensations you may experience in your arms, legs, hands, and feet and problems these sensations may cause for you.
* You will complete the symptom questionnaire that has questions about pain, fatigue, nausea, disturbed sleep, difficulty remembering, mood, work, and enjoyment of life.
* You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities. This should take about 2-3 minutes.
* You will be asked about any side effects you may have experienced.

End-of-Study Visit:

Once you have completed the study medication (minocycline or placebo) after Week 10, you will be asked to return for an end-of-study visit:

* You will have a physical exam.
* Your complete medical history will be recorded, and you will be asked about any drugs you may be taking.
* Your performance status will be recorded.
* Blood (about 2-3 teaspoons) will be drawn for routine tests.
* Blood (about 4 teaspoons) will be drawn to test for certain cytokines.
* You will have a nerve function test and a neuro-cognitive test.
* You will complete the questionnaire that has questions about unusual sensations you may experience in your arms, legs, hands, and feet and problems these sensations may cause for you.
* You will complete the symptom questionnaire that has questions about pain, fatigue, nausea, disturbed sleep, difficulty remembering, mood, work, and enjoyment of life.
* You will complete a questionnaire that asks about high likely you are to doze off or fall asleep while doing certain activities. This should take about 2-3 minutes.
* You will be asked about any side effects you may have experienced.

If intolerable side effects occur, or if thalidomide and/or bortezomib for the myeloma is stopped, you will be taken off study.

This is an investigational study. Minocycline is commercially available and FDA approved for use in other diseases, such as infections caused by bacteria. Minocycline is not FDA approved for the treatment of neuropathy. In neuropathy, it is currently being used in research only. Up to 142 patients will take part in this study. All will be enrolled at MD Anderson.

Prevention of Treatment Induced Neuropathy in Multiple Myeloma

A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma

Touch detection testing prior to each cycle of multiple myeloma therapy +/- 3 business days until week 10 where measurements summarized by descriptive statistics at each time point for both treatment groups.

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Laryngeal Diseases

Psychotropic Drugs

Cardiotonic Agents

Bupropion

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

David I. Rosenthal, MD, MA, BA

The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.

The Study Drugs:

It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 3 study drugs that may help to reduce side effects such as fatigue, pain, sleep disturbance, difficulty swallowing, and lack of appetite. The study drugs will be tested alone and in combination with each other.

* Armodafinil is designed to prevent excessive sleepiness.
* Bupropion and minocycline each may reduce inflammation, which may help to reduce other symptoms. Bupropion is a drug for depression. Minocycline is an antibiotic (a drug to treat infection).

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 8 groups. You may be assigned to receive no study drugs, 1 study drug, a combination of 2, or all 3 of the study drugs.

During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. The study drugs are being tested to learn if they can help control symptoms. All participants will be able to receive standard care for head and neck cancer outside of the study.

Neither you nor the study staff will know if you are receiving the study drugs and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug(s) you are receiving.

Study Drug Administration:

You will take the study drugs/placebos 2 times every day for up to 10 weeks. You will take 1 or more study drug(s) or placebos by mouth each time, as instructed by the study doctor. If you have trouble swallowing the study drugs/placebos, they can be crushed just before taking them. You will be given information sheets on how to take the study drugs/placebos.

You will be given a daily diary to write down when you take the study drugs/placebos. You should bring your study drugs/placebos to the clinic to every study visit. You should also bring your diary to every study visit.

Symptom Questionnaire:

Throughout the study, you will be asked to fill out a symptom questionnaire. You will be asked about symptoms you may be experiencing and how they may be interfering with your daily activities. When you are in the clinic, the questionnaire can be completed by paper and pen with the study staff or by entering your answers into a computer. When you are away from the clinic, the questionnaire may be completed either through a phone call with the study staff or through a phone call from the interactive voice response (IVR) system. The symptom questionnaire will take up to 5 minutes each time. The study staff will give you the information you need to complete the questionnaire through the IVR system.

During Weeks 1-10, you will complete the symptom questionnaire 2 times a week. During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.

If you would like, you can fill out a paper version of the questionnaire instead of using the phone system.

Study Visits:

Before you begin chemoradiation:

* You will fill out 6 questionnaires about pain and other symptoms, your mood, your tobacco and alcohol use, and the quality of your life. This should take about 15 minutes.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.
* If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy. This will also be done at about Weeks 4 and 7, at the first follow-up visit after radiation treatment, and 30 days after the study drugs are stopped.

At about Week 4 of chemoradiation:

* You will fill out 1 quality-of-life questionnaire. This should take about 2-3 minutes.
* You will be asked three questions about smoking after the start of chemoradiation therapy.
* You will have a blood coagulation test, called PT-INR, to make sure your blood clots normally.

During the last week of chemoradiation (about Week 7):

-You will fill out 3 questionnaires about your symptoms, mood, and quality of life. This should take about 10 minutes.

After about Week 7, the study staff will call you 2 times per week to check on you until Week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call may take longer.

At about Week 10 and at your first follow-up visit after your chemoradiation treatment:

* You will fill out 3 questionnaires about your symptoms, mood, and quality of life.
* You will fill out 2 questionnaires that ask about your smoking history and changes in your tobacco use during the study. This will take a few minutes.
* You will be asked to fill out another questionnaire that asks about your satisfaction with the study drug(s). For example, you will be asked if you thought the study drugs helped to control the symptoms, if you would recommend the study drugs to other patients, and if you had problems taking the study drugs. This will take a few minutes.
* In addition, at your first follow-up visit after your chemoradiation treatment, you will have a blood coagulation test, called PT INR, to make sure your blood clots normally.

Length of Study:

You will take the study drug(s)/placebo for up to 10 weeks, if the doctor thinks it is in your best interest. You will fill out the symptom questionnaires by phone until 16 weeks. You will no longer be able to take the study drug(s)/placebo if you experience intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The different possible combinations of these drugs being used in this study are investigational.

Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.

Symptom Burden in Head and Neck Cancer

A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Head and Neck Cancer

Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.

Placebo by mouth 2 times every day.

Placebo: 1 by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion 100 mg by mouth two times a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Armodafinil 150 mg by mouth once a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Bupropion

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Minocycline + Bupropion

Armodafinil 150 mg by mouth once a day.

Minocycline 100 mg by muth two times a day.

Bupropion 100 mg by mouth two times a day.

Armodafinil: 150 mg by mouth once a day.

Minocycline: 100 mg by mouth twice a day.

Bupropion: 100 mg by mouth twice a day.

Armodafinil + Minocycline + Bupropion

<=18 years

Study halted due to low enrollment (one participant). No analysis completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minocycline Study in Pancreatic Cancer Patients	NCT01693523	Pancreatic Canc...	Minocycline Placebo Questionnaires	18 Years -	M.D. Anderson Cancer Center
Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma	NCT01793051	Myeloma	Minocycline Placebo Questionnaires	18 Years -	M.D. Anderson Cancer Center
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients	NCT01906008	Colorectal Canc...	Minocycline Placebo Questionnaires Sensory Test	18 Years -	M.D. Anderson Cancer Center
Prevention of Treatment Induced Neuropathy in Multiple Myeloma	NCT01283997	Myeloma	Placebo Minocycline	18 Years -	M.D. Anderson Cancer Center
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients	NCT01906008	Colorectal Canc...	Minocycline Placebo Questionnaires Sensory Test	18 Years -	M.D. Anderson Cancer Center
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
Symptom Burden in Head and Neck Cancer	NCT01219673	Head And Neck C...	Placebo Armodafinil Minocycline Bupropion	18 Years - 65 Years	M.D. Anderson Cancer Center
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	NCT01048983	Non Small Cell ...	Armodafinil Bupropion Minocycline Curcumin Telephone Quest...	18 Years - 65 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for solodyn

Every month we try and update this database with for solodyn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for solodyn

Every month we try and update this database with for solodyn cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for solodyn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.