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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aprepitant; BB 1101; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Granisetron

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