Neoplasms

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Glioma

Nausea

Vomiting

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Signs and Symptoms, Digestive

Acute Graft Versus Host Disease

Neuroepithelioma

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Ondansetron

Temozolomide

Fosaprepitant

Aprepitant

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.

On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.

On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).

aprepitant

On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.

ondansetron

Mary Lou Affronti, DNP, RN, MHSc, ANP

Katherine B Peters, MD, PhD

Patients diagnosed with malignant glioma who are receiving temozolomide will be accrued in this open label, phase 2, randomized single institution trial of aprepitant in combination with ondansetron versus ondansetron alone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Sixty-eight (68) patients will be randomized to each arm of the study.

Sixty-eight (68) patients will be randomized to each arm of the study. Patient randomization will be stratified by grade of tumor (1 or 2 versus 3 or 4) and the number of prior progressions (0 or 1 versus 2). Within each of the 4 strata defined by these factors, a permuted block randomization scheme will be used to assign patients to receive either aprepitant in combination with ondansetron or ondansetron alone.

Though the study is comparative, the goal of the study is to determine whether aprepitant is worthy of further investigation in this setting, and not to make definitive statements about the comparative effectiveness of ondansetron treatment with or without aprepitant.

Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide

A Randomized Open Label Phase II Trial of Aprepitant (Emend) in Combination With Ondansetron Compared to Standard 5HT3 Serotonin Antagonist (Ondansetron) in the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Glioma Patients Receiving a Temozolomide Based Regimen

Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).

CR is the proportion of patients with no emetic episode and no rescue medication. (1) Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting \<5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2-7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated ultinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT)/Osoba survey.

Patients' global satisfaction with the antiemetic regimen is measured using the Osoba survey, which was administered on days 1-7. This survey asks patients "In the past 24 hours, did vomiting or dry heaves a) interfere with your appetite, b) affect your sleep, c) interfere with your physical activities, d) interfere with your social life, and e) interfere with your enjoyment of life?" Patients responded on a scale of 1-4 ranging from 'Not at all' to 'Very much.' Global satisfaction was defined as responding 'Not at all' for all questions related to vomiting/retching for each study day. The proportion of patients responding 'Not at all' for all Osoba vomiting/retching questions over the study period is reported.

Median time in days to first emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, among those patients experiencing an emetic episode or need of rescue medication

Merck Sharp & Dohme LLC

Katy Peters

Assistant Professor

On day 1, patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). Additionally, On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.

Aprepitant: On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).

Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.

Aprepitant+Ondansetron

On days 1-5, patients receive a single dose of Ondansetron 30 minutes before the receiving their prescribed dose of 5-day oral temozolomide.

Ondansetron: On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.

Ondansetron Alone

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Proportion of Patients Achieving Complete Control (CC)

Acute CINV CR

Delayed CINV CR

Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)

2 patients in the Aprepitant + Ondansetron arm and 4 patients in the Ondansetron arm did not have adequate survey data for this analysis

Patient's Global Satisfaction With the Antiemetic Regimen

This analysis only includes those patients no achieving complete control (no emetic episode or need for rescue medication throughout the 7-day study period).

Time to Treatment Failure

Overall Study

Blood and Lymph Conditions

Syndrome

Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Cytarabine

Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.

8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.

Jorge Cortes, MD

The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.

Cytarabine is a drug that is used to treat AML and high-risk MDS. It is known to cause nausea and/or vomiting. All patients that receive cytarabine also receive drugs to help prevent these side effects.

The Study Drugs:

Ondansetron is designed to block the action of serotonin, a substance in the brain that causes chemotherapy-related nausea and vomiting.

Aprepitant is designed to block a different natural substance in the brain that causes chemotherapy-related nausea and vomiting.

Study Groups:

If you are found eligible 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 receive ondansetron.

If you are in Group 2, you will receive ondansetron and aprepitant.

Study Drug Administration:

Both groups will receive ondansetron by vein from 30 minutes before receiving chemotherapy until 6 to12 hours after chemotherapy. The length of the chemotherapy infusion will be different for all patients.

If you are in Group 2, in addition to ondansetron, you will take 1 capsule of aprepitant every morning while receiving chemotherapy. You will take your last dose of aprepitant the day after your chemotherapy infusion is completed. If you miss a dose of aprepitant, you can take it as soon as you remember.

Study Diary:

You will fill out a study diary every day for the 7 days after the chemotherapy. You will record how often you experience nausea and/or vomiting and any time you need other medications during this study. It should take about 5 minutes to complete each time.

Length of Study:

You will be on study for up to 7 days. You will be taken off study if intolerable side effects occur.

Blood Draws:

Blood (about 1 teaspoon) will be drawn for routine tests after your last dose (+/- 3 days) of study drug.

This is an investigational study. Ondansetron and aprepitant are both FDA approved and commercially available for the prevention of chemotherapy-related nausea and vomiting. Using the drugs in combination is investigational.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.

Ondansetron Versus Aprepitant Plus Ondansetron for Emesis

Comparative Trial Ondansetron Alone Versus Combination of Ondansetron Plus Aprepitant for Prevention of Nausea and Vomiting With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine

Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.

Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.

M.D. Anderson Cancer Center

Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.

Group 1: Ondansetron

Group 2: Ondansetron + Aprepitant

United States

Region of Enrollment

Registered eligible participants who received one dose of study medication were evaluable for toxicity but had to receive at least five doses to be evaluable for response. Only 90 participants (46 on Group 1 and 44 on Group 2) had one or more doses of study medication.

Jorge Cortes, MD / Professor

Complete Response

Partial Response

No Response

Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.

Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.

Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide	NCT01450826	Nausea Vomiting Glioma	aprepitant ondansetron	18 Years -	Duke University
Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide	NCT01450826	Nausea Vomiting Glioma	aprepitant ondansetron	18 Years -	Duke University
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis	NCT00954941	Hematologic Dis... Acute Myelogeno... Myelodysplastic... Chronic Myeloge...	Ondansetron Aprepitant	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for emend

Every month we try and update this database with for emend 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 emend

Every month we try and update this database with for emend 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 emend 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.