Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Not Applicable

Completed

• Conditions: Breast Cancer; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Nausea and Vomiting; Neuroblastoma; Ovarian Cancer; Testicular Germ Cell Tumor
• Interventions: Drug: Aprepitant; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Granisetron hydrochloride

• Registration Number: NCT00293384
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.

Secondary

* Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.

* Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.

* Identify side effects of the addition of aprepitant to this regimen in these patients.

OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Primary Completion: 2009-06
• Study Completion: 2012-02
• Results First Submitted: 2014-05-12
• Results First Submitted QC: 2014-09-26
• Results First Posted: 2014-10-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aprepitant, Dexamethasone, Cytoxan & Kytril	Cyclophosphamide	Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.
Aprepitant, Dexamethasone, Cytoxan & Kytril	Granisetron hydrochloride	Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.
Aprepitant, Dexamethasone, Cytoxan & Kytril	Aprepitant	Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.
Aprepitant, Dexamethasone, Cytoxan & Kytril	Dexamethasone	Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Controlled Acute Vomiting	at 0-24 hours	No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.

Secondary Outcome Measures

Name	Time	Method
Delayed Vomiting Controlled	at 25-120 hours
Toxicity Grade 3, 4, or 5	at 0-120 hours

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States