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

Information source: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Chronic Myeloproliferative Disorders; Gestational Trophoblastic Tumor; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Nausea and Vomiting; Neuroblastoma; Ovarian Cancer; Testicular Germ Cell Tumor

Intervention: Aprepitant (Drug); Cyclophosphamide (Drug); Dexamethasone (Drug); Granisetron hydrochloride (Drug)

Phase: N/A

Status: Completed

Sponsored by: Barbara Ann Karmanos Cancer Institute

Official(s) and/or principal investigator(s):
Muneer H. Abidi, MD, Study Chair, Affiliation: Barbara Ann Karmanos Cancer Institute

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.

Clinical Details

Official title: Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Proportion of Participants With Controlled Acute Vomiting

Secondary outcome:

Delayed Vomiting Controlled

Toxicity Grade 3, 4, or 5

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Undergoing autologous peripheral blood stem cell transplantation and stem cell

mobilization using cyclophosphamide

- Candidate (per institutional requirements) for autologous peripheral blood stem cell

transplantation

- No psychiatric illness or multi-system organ failure

- No nausea at baseline

PATIENT CHARACTERISTICS:

- SWOG performance status 0-2

- Fewer than 5 alcoholic drinks per day within the past year

- No current illness requiring chronic systemic steroids or requirement for chronic use

of anti-emetics

- No gastrointestinal obstruction or active peptic ulcer disease

- AST and ALT ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Creatinine ≤ 2 mg/dL

- No known hypersensitivity to any component of the study regimen

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- No unrelenting hiccups

PRIOR CONCURRENT THERAPY:

- No chronic therapeutic warfarin > 1 mg dose per day

- No other concurrent investigational agents

- No concurrent oral contraceptives (except for stopping menses), tolbutamide,

phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride

- No concurrent illegal drugs

Locations and Contacts

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2004
Last updated: August 7, 2015

Page last updated: August 23, 2015

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