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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00293384
First received: February 16, 2006
Last updated: September 26, 2014
Last verified: September 2014

February 16, 2006
September 26, 2014
October 2004
June 2009   (final data collection date for primary outcome measure)
Proportion of Participants With Controlled Acute Vomiting [ Time Frame: at 0-24 hours ] [ Designated as safety issue: Yes ]
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
Not Provided
Complete list of historical versions of study NCT00293384 on ClinicalTrials.gov Archive Site
  • Delayed Vomiting Controlled [ Time Frame: at 25-120 hours ] [ Designated as safety issue: Yes ]
  • Toxicity Grade 3, 4, or 5 [ Time Frame: at 0-120 hours ] [ Designated as safety issue: Yes ]
Not Provided
Overall Nausea Controlled [ Time Frame: at 0-120 hours ] [ Designated as safety issue: Yes ]
Not Provided
 
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Nausea and Vomiting
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • Drug: Aprepitant
    Aprepitant 80mg once daily in the morning on days 2 and 3
    Other Name: 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
    • Diodex
    • Hexadrol
    • Maxidex
    • Dexamethasone Sodium Phosphate
    • Dexamethasone Acetate
  • Drug: Granisetron hydrochloride
    Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
    Other Name: KYTRIL®
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.

Interventions:
  • Drug: Aprepitant
  • Drug: Cyclophosphamide
  • Drug: Dexamethasone
  • Drug: Granisetron hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2012
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00293384
CDR0000456201, P30CA022453, WSU-D-2797, WSU-0504001728
Yes
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Muneer H. Abidi, MD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP