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

Barbara Ann Karmanos Cancer Institute40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

AprepitantDRUG

Aprepitant 80mg once daily in the morning on days 2 and 3

CyclophosphamideDRUG

Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

DexamethasoneDRUG

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Granisetron hydrochlorideDRUG

Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of Participants With Controlled Acute Vomiting

No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.

Time frame: at 0-24 hours

Secondary Outcomes

Delayed Vomiting Controlled

Time frame: at 25-120 hours

Toxicity Grade 3, 4, or 5

Time frame: at 0-120 hours