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

NCT00293384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-15

Study results available
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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.

Conditions

Interventions

DRUG

Aprepitant

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

DRUG

Cyclophosphamide

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

DRUG

Dexamethasone

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

DRUG

Granisetron hydrochloride

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Muneer H. Abidi, MD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-06-30
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293384 on ClinicalTrials.gov