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

February 12, 2016 updated by: Muneer Abidi, Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant, Dexamethasone, Cytoxan & Kytril

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.
Drug: Aprepitant
Aprepitant 80mg once daily in the morning on days 2 and 3
Other Names:
  • Emend
Drug: Cyclophosphamide
Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Other Names:
  • Cytoxan®
  • Neosar®
Drug: Dexamethasone
Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Other Names:
  • Decadron
  • Hexadrol
  • Dexamethasone Acetate
  • Maxidex
  • Dexamethasone Sodium Phosphate
  • Diodex
Drug: Granisetron hydrochloride
Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Other Names:
  • KYTRIL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Controlled Acute Vomiting
Time Frame: at 0-24 hours
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
at 0-24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Delayed Vomiting Controlled
Time Frame: at 25-120 hours
at 25-120 hours
Toxicity Grade 3, 4, or 5
Time Frame: at 0-120 hours
at 0-120 hours

Other Outcome Measures

Outcome Measure
Time Frame
Overall Nausea Controlled
Time Frame: at 0-120 hours
at 0-120 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Muneer H. Abidi, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000456201
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-D-2797 (Other Identifier: Karmanos Cancer Institute)
  • WSU-0504001728 (Other Identifier: Wayne State University - Human Investigation Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on Aprepitant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe