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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00293384
First received: February 16, 2006
Last updated: February 12, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention
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
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Granisetron hydrochloride

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Hairy Cell Leukemia Lymphosarcoma Mycosis Fungoides Diffuse Large B-Cell Lymphoma Acute Lymphoblastic Leukemia Myeloid Leukemia Chronic Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Cutaneous T-cell Lymphoma Lymphoblastic Lymphoma Ovarian Cancer Ovarian Epithelial Cancer Follicular Lymphoma Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic B-cell Lymphoma Mantle Cell Lymphoma Myelofibrosis Chronic Myeloproliferative Disorders Hodgkin Lymphoma Neuroblastoma Testicular Cancer Lymphoma, Large-cell Sezary Syndrome Burkitt Lymphoma Chronic Myelomonocytic Leukemia Ovarian Germ Cell Tumor Gestational Trophoblastic Tumor Myelodysplastic/myeloproliferative Disease Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia Anaplastic Plasmacytoma Neuroepithelioma
U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Overall Nausea Controlled [ Time Frame: at 0-120 hours ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2004
Study Completion Date: February 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293384

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Muneer H. Abidi, MD Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Muneer Abidi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00293384     History of Changes
Other Study ID Numbers: CDR0000456201  P30CA022453  WSU-D-2797  WSU-0504001728 
Study First Received: February 16, 2006
Results First Received: May 12, 2014
Last Updated: February 12, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
nausea and vomiting
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative neoplasm, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia
Syndrome
Breast Neoplasms
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neuroblastoma
Nausea
Vomiting
Neoplasms, Germ Cell and Embryonal
Myeloproliferative Disorders
Plasmacytoma
Testicular Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders

ClinicalTrials.gov processed this record on August 29, 2016