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

Barbara Ann Karmanos Cancer Institute

Status: Completed

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

Treatments: Drug: Granisetron hydrochloride; Drug: Aprepitant; Drug: Dexamethasone; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00293384

CDR0000456201

WSU-D-2797 (Other Identifier)

P30CA022453 (U.S. NIH Grant/Contract)

WSU-0504001728 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Aprepitant, Dexamethasone, Cytoxan & Kytril

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Drug: Dexamethasone

Drug: Aprepitant

Drug: Granisetron hydrochloride