Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Dyspnea

Respiratory Aspiration

Hematologic Diseases

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Central Nervous System Depressants

Dexamethasone

Dexamethasone acetate

BB 1101

Cocaine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.

Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.

Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.

Placebo

Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Questionnaires

Patient to blow into spirometry machine 1 time a day to test lung function.

Spirometer

Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.

Phone Calls

David Hui, MD

The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo.

Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath.

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.

Baseline Tests:

If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaires. The following tests and procedures will be performed:

* Information will be collected from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
* Your breathing rate will be measured.
* The amount of oxygen in your body will be measured using a machine that clips on your finger.
* You will blow into a device called a spirometer a few times to measure your lung function.
* You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety, and drowsiness. The second questionnaire asks about your sensation of breathing. The third questionnaire asks you to rate the intensity of your shortness of breath. The last questionnaire asks about your quality of life. These questionnaires should take a total of about 40 minutes to complete.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:

* If you are in Group 1, you will receive dexamethasone.
* If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7 days.

You will have an equal chance of being assigned to either group. 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/Placebo Administration:

After your baseline tests, you will be given a supply of either the study drug or the placebo to bring home.

Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.

After the first 7 days, no matter which group you have been assigned to, you will only take 1 dexamethasone capsule twice a day for 7 more days

You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the capsules with food and 8 ounces of water.

You will also receive a portable spirometer to test your lung function. You should blow into the machine 1 time a day.

Study Visits/Calls:

On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your capsule boxes with you if you come to the clinic, or have them with you if you are called so the study staff can count the number of capsules. The following tests and procedures will be performed:

* You will be asked to complete the same 4 questionnaires you completed during your baseline tests.
* You will also be asked about any side effects you may be having and if you think the study drug is helping your shortness of breath.
* You will blow into a spirometer to measure your lung function.

During the 14 days you will be taking either the study drug or the placebo on the study, you will be called by phone 1 time each day to ask you about your level of shortness of breath and to remind you to take the capsules. These calls should last about 5 minutes.

Length of Study:

You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the follow-up calls and visit.

This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath is investigational.

Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Dexamethasone Dyspnea Study

A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients

Number of participants who completed the dyspnea numeric rating scale on Day 7

The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.

Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.

M.D. Anderson Cancer Center

As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.

Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Intervention Group (Dexamethasone)

Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Controlled Group (Placebo)

Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High School or less

College and above

Education

Mesothelioma

Non-small cell lung cancer

Small cell lung cancer

Other

Cancer Type

Localized

Locally advanced

Metastatic/recurrent

Cancer Stage

COPD

Asthma

Comorbidities

Data included all participants who were randomized.

David Hui, MD/ Associate Professor, Palliative Care Medicine

Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm

Number of Participants Who Completed the Dyspnea Numeric Rating Scale

Day 4

Day 7

Day 14

The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire.

Edmonton Symptom Assessment System Dyspnea Score

The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire.

Dyspnea Numeric Rating Score (Now)

The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Infertility

Rheumatic Diseases

Collagen Diseases

Genital Diseases

Urogenital Diseases

Connective Tissue Diseases

Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use.

The ovarian tissue will be removed at a UK Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or REI physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007.

Ovarian Cryopreservation

Lars Wagner, MD

The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future.

Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years.

By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.

The research procedures will be conducted at the University of Kentucky (UK) Medical Center.

Participants in the study will provide ovarian tissue cryopreservation for their own personal use.

The duration of the study will be until the participant reaches age 41 years. Participants will be broken out into four categories:

Participants will have surgical removal of their ovarian tissue using the methods determined by their surgeon based on their medical/surgical diagnosis or treatment. Participants in one of the following categories will participant in the study:

1. Participants have elected to have one or both ovaries removed for the treatment or prevention of disease.
2. Participants who have elected to have surgery to remove all or part of one or both ovaries for medical reasons where cryopreservation of the remaining limited portions of normal ovarian cortex is the only option for fertility preservation at the time (except that ovarian cortex from the ovary that contains the mass will not be cryopreserved).
3. Participants who have elected to have surgery to remove all or part of one or both ovaries for medical reasons where cryopreservation of the remaining limited portions of normal ovarian cortex is the only option for fertility preservation at the time but who cannot or will not provide tissue to the research pool (except that ovarian cortex for the ovary that contains the mass will not be cryopreserved).
4. Participants who have elected to have one or part of one ovary removed, solely for the purpose of fertility preservation because they are not candidates for or choose not to use more mature fertility preservation technologies.

Participants undergoing elective removal of an ovary (category C above) will undergo a procedure called laparoscopy to remove the ovary. This surgery will be performed under general anesthesia and one ovary will be removed in total through an instrument channel employing standard techniques of operative laparoscopy. This surgical procedure is performed solely for fertility preservation but will potentially be coordinated with another procedure such as placement of a central line for future chemotherapy or laparotomy for another purpose. Although only one ovary will be removed, both of the participant's ovaries must appear normal for the procedure to be completed. The ovary to be removed will be chosen at the time of surgery based on appearance and ease of removal. After the surgery is complete, the participant will not have any further procedures except for a routine post-operative visit. A 0.5 cm cross section from the short axis of the ovary will be provided to the Department of Pathology for routine histological evaluation, and the remaining tissue will be processed for cryopreservation. If pathology finds evidence of cancer in the ovarian tissue provided at surgery, they may request that all of the participant's tissue (even tissue that has been frozen for their use) be returned to pathology for a more detailed examination. In this case, no tissue is available for the participant to use for fertility preservation purposes.

b. Cryopreservation: Ovarian tissue will be cryopreserved under the protocol originally established by the National Physicians Cooperative of the Oncofertility Consortium. The ovarian tissue will be removed at a UK or Norton Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or a reproductive endocrinology and infertility (REI) physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007. The procedure for cryopreservation/vitrification may be modified as improvements become available.

The designated laboratory directors at UK responsible for the overall quality of the ovarian tissue cryopreservation.

c. Tissue storage: Cryopreserved participant tissues will be transferred to Reprotech, Ltd (RTL) in Roseville, Minnesota for storage and subsequent release. Reprotech, Ltd. is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissues. Based on the extended periods of time that these tissues are likely to be stored Reprotech, Ltd. provides maximum flexibility for the participants involved. In this way, the participant can store tissues as long as they wish and ship them to a fertility treatment center of their choice at the time of use. The participant can determine how her own tissue will be used as technology changes and based on her unique circumstances. Reprotech, Ltd. does not perform fertility treatments and is not affiliated with any fertility center so there is no potential conflict of interest.

d. Infectious Disease Screening and Testing: Banking and subsequent use of ovarian tissue is regulated by the Food and Drug Administration (FDA). In order to comply with current tissue banking regulations and to be prepared for any future changes in regulations while these ovarian tissues are in storage, participants will be tested and screened for a number of infectious diseases prior to banking ovarian tissue.The testing will include but not be limited to testing for Hepatitis B and C and HIV. The testing that will be performed will be testing that is mandated for donors of leukocyte rich tissues and must be performed within 7 days of tissue procurement. In this way, the tissue could potentially be used by the participant herself and it could also be suitable for use in another individual (such as a surrogate) in the future if indicated by the participant's medical diagnosis.

If the ovarian tissue was vaginally removed during surgery the sites will also collect a vaginal swab from the participant for Gonorrhea and Chlamydia testing.

Please note that if the HIV screening test is positive, a confirmatory test will then be performed. Should the screening tests detect that participants are infected with HIV this information will be communicated confidentially to them through personal contact by a qualified professional. Participants will meet with a qualified professional who will provide HIV counseling.

There are risks associated with this study and those risks are outlined in the study informed consent document.

Benefit vs. Risk: There is no guarantee that participants will get any benefit from taking part in this study, although 86 babies have been born from transplanted frozen ovarian tissue. A females participation may provide her with a means to restore her fertility and reproductive hormonal function in the future as observed in previous reports. A females participation may also advance the investigator's understanding of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by the participant and other patients at some point in the future. A females participation may also advance the investigator's knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help the participant or others in the future. However, there is a significant possibility that there may be no direct benefit to the participant from her participation in this research study. Specifically, there is the possibility that ovarian cryopreservation will not result in successful pregnancy in the future.

There are alternatives to taking part in this study and those alternatives are addressed in the study informed consent document.

Costs: All expenses related to the research procedure will be covered by the research funds and include the oophorectomy, anesthesia, pathologist's fees and infectious disease testing.

Either the participant or their insurance company, Medicare or Medicaid will be responsible for the costs of all care and treatment that the participant would receive during this study that she would normally receive for her condition. These are costs that are considered medically reasonable and necessary and will be part of the care she receives if she does not take part in this study. This includes the confirmatory HIV testing and the follicle stimulating hormone (FSH) testing.

There are also costs associated with the handling, processing, shipping and storage of ovarian tissue. Those costs are outlined in the study informed consent document.

In the unlikely event that the participant is hurt or injured while participating in this study the medical costs related to their care and treatment will be their responsibility or submitted to their insurance.

Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment

Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 1 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.

The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 5 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.

Vlad Radulescu

Professor

Neoplasms

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Leukemia, Lymphoid

Anemia

Anemia, Aplastic

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Large Granular Lymphocytic

Neoplasms by Histologic Type

Bone Marrow Diseases

Precancerous Conditions

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Bone Marrow Failure Disorders

Pancytopenia

Leukemia, T-Cell

Chronic Graft Versus Host Disease

Aplastic Anemia

Chronic Lymphocytic Leukemia

Aggressive NK Cell Leukemia

T-cell Large Granular Lymphocyte Leukemia

Alemtuzumab

Antineoplastic Agents, Immunological

Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.

10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.

Tapan Kadia, MD

The goal of this clinical research study is to determine the effectiveness of alemtuzumab in patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety of alemtuzumab will also be studied.

The Study Drug:

Alemtuzumab is designed to attach to a protein that is found on certain immune cells, which may cause the cell to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive alemtuzumab on Days 1-10 of one 28-day cycle. It will be given either by vein over 2 hours or by injection under the skin 1 time a day. Your doctor will tell you how the drug will be given.

In order to get alemtuzumab provided for your treatment, the study staff will be filling out a form with your name and medical information (protected health information) for the company as part of the Campath Distribution Program.

All participants will receive the same dose of alemtuzumab unless the starting dose causes intolerable side effects. If this happens, all future participants will receive a lower dose.

Depending on your doctor's decision, to lower the risk of side effects you will receive Tylenol (acetaminophen) and Benadryl (diphenhydramine) or other drugs such as steroids (either by mouth or by a short infusion by vein), 30 minutes before each alemtuzumab dose.

If you are receiving alemtuzumab and have chills during the infusion, you may receive Demerol (meperidine hydrochloride, a painkiller) to help control them.

Starting on Day 1 and continuing at least 8 weeks after the last dose of study drug, you will be given 2 antibiotics to help fight infection. You will take Valacyclovir (or a similar drug) 1 time each day. You will take Trimethoprim/Sulfamethoxazole (or a similar drug) 2 times a day, 3 times per week. You will take both antibiotics by mouth.

Study Visits:

At Week 1:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.

At Weeks 2-4, blood (about 1 tablespoon) will be drawn for routine tests.

Beginning at Week 5 (+/- 3 days) and then 1 time monthly:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.

At Week 12 (+/- 3 days) (end of the 3rd month), you will have a bone marrow aspiration and/or biopsy to test for chromosome abnormalities (if chromosomes were abnormal at screening) and to check the status of the disease. You may have additional bone marrow aspirations or biopsies if your doctor feels they are necessary.

You will be asked about any side effects you may be having at each of your study visits. At any time during the study, if the doctor thinks it is needed, you will have a chest x-ray, a CT scan, or a PET scan to check the status of the disease.

Length of Study:

You will receive only one cycle of the study drug. Your participation on the study will be over after you have completed the end-of-study visit. You will be taken off study early if the disease gets worse or intolerable side effects occur.

End-of Study-Visit:

When you come off study you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

* Blood (about 2 tablespoons) will be drawn for routine tests.
* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have a bone marrow aspiration and/or biopsy to check for chromosome abnormalities, test for low levels of leukemia or lymphoma, to check the status of the disease, and molecular testing. Molecular tests are designed to look at the way the different parts of a cell (including DNA, RNA, and proteins) work together.
* Blood (about 2 teaspoons) will be drawn to check levels of T-cells and immunoglobulins.

This is an investigational study. Alemtuzumab is FDA-approved for the treatment of some patients with B-cell chronic lymphocytic leukemia (CLL). The use of alemtuzumab to treat MDS, aplastic anemia, or T-cell large granular lymphocytic leukemia is investigational.

Up to 29 participants will take part in this study. All participants will be enrolled at MD Anderson.

Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)

Phase II Pilot Study Of Alemtuzumab In Patients With Low Or INT-1 Risk Myelodysplastic Syndrome (MDS), Aplastic Anemia (AA), Or T-Cell Large Granular Lymphocytic Leukemia (T-LGL)

Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count \<100 x 10\^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10\^9/L.

Age, Categorical

Complete Remission (CR)

Partial Remission (PR)

Hematologic Improvement

Disease Progression

Stable Disease (SD)

One subject's response was indeterminate due to the absence of end of therapy assessments.

Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Nausea

Vomiting

Hematologic Neoplasms

Signs and Symptoms, Digestive

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Dermatologic Agents

Anti-Infective Agents

Ondansetron

Cytarabine

Palonosetron

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Standard of care, Ondansetron 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy treatment.

Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy treatment, given over 30 seconds, 30 minutes before chemotherapy treatment.

8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy.

Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy.

Jorge Cortes, MD

The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia that can lead to further medical problems, such as malnutrition, dehydration, electrolyte imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat AML and high-risk MDS, is known to cause nausea and/or vomiting, so all patients that receive chemotherapy with cytarabine also need to receive medication to prevent these side effects.

One standard-of-care drug to treat chemotherapy-related nausea and vomiting is called Ondansetron. Palonosetron is a new drug similar to Ondansetron that is designed to stay longer in the bloodstream. Researchers want to find out if palonosetron can prevent nausea and vomiting better than ondansetron.

Women who are able to have children must have a negative blood or urine pregnancy test before starting treatment.

If you are still eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) to one of 3 treatment groups. Participants in the first group will be given Ondansetron as an intravenous (IV--through a needle in your vein) continuous infusion, from 30 minutes before your chemotherapy treatment until 12 hours after chemotherapy ends. This is considered the standard of care.

Participants assigned to the second treatment group will be given palonosetron once a day by IV injection for 5 days. Each dose will be given over a period of 30 seconds, 30 minutes before your chemotherapy treatment.

Participants assigned to the third treatment group will be given palonosetron once a day by IV injection, on Days 1, 3, and 5 of chemotherapy treatment. Each dose will be given over a period of 30 seconds, 30 minutes before your chemotherapy treatment.

No matter what group you are assigned to, you will receive extra medication for nausea and/or vomiting as needed.

You will be asked to fill out a study diary daily for 7 days, and it should take you no longer than 10 minutes to complete. The diary will be used to record the number of episodes of nausea and/or vomiting you experience during this study, as well as to record any need for extra medications, and to help researchers learn which of the 2 drugs helps the best to improve participants' quality of life (such as sleep, daily activities, and your ability to think and reason).

You will be taken off study if intolerable side effects occur.

This is an investigational study. The Food and Drug Administration (FDA) has approved palonosetron and Ondansetron for the prevention of chemotherapy-related nausea and vomiting, and both drugs are commercially available. Up to 150 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.

Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine

Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as \< or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.

Eisai Inc.

Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Ondansetron: Standard of Care

Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.

Palonosetron Group 1 (5 Days)

Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.

Palonosetron Group 2 (3 Days)

Age Continuous

Jorge Cortes, MD / Professor

Analysis was per protocol. Seven patients were excluded from the efficacy analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dexamethasone Dyspnea Study	NCT01670097	Advanced Cancer... Hematologic Dis... Solid Tumors	Dexamethasone Placebo Questionnaires Spirometer Phone Calls	18 Years -	M.D. Anderson Cancer Center
Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment	NCT02678910	Cancer Hematologic Dis... Rheumatologic D... Infertility	Ovarian Cryopre...	12 Years - 41 Years	University of Kentucky
Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)	NCT01191749	Leukemia	Alemtuzumab	-	M.D. Anderson Cancer Center
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting	NCT01031498	Acute Myelogeno... Chemotherapy-in...	Ondansetron Palonosetron	18 Years -	M.D. Anderson Cancer Center
SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)	NCT01352520	CD-30 Positive ... Lymphoma, Prima... Lymphomatoid Pa... Mycosis Fungoid... Skin Lymphoma Cutaneous Lymph... Lymphoma Hematologic Dis...	SGN-35	18 Years -	M.D. Anderson Cancer Center
Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)	NCT01191749	Leukemia	Alemtuzumab	-	M.D. Anderson Cancer Center
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis	NCT00954941	Hematologic Dis... Acute Myelogeno... Myelodysplastic... Chronic Myeloge...	Ondansetron Aprepitant	18 Years -	M.D. Anderson Cancer Center

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