Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00293384
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : October 3, 2014
Last Update Posted : March 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Delayed Vomiting Controlled [ Time Frame: at 25-120 hours ]
  2. Toxicity Grade 3, 4, or 5 [ Time Frame: at 0-120 hours ]

Other Outcome Measures:
  1. Overall Nausea Controlled [ Time Frame: at 0-120 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293384


Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Muneer H. Abidi, MD Barbara Ann Karmanos Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Muneer Abidi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00293384    
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 )
First Posted: February 17, 2006    Key Record Dates
Results First Posted: October 3, 2014
Last Update Posted: March 15, 2016
Last Verified: February 2016
Keywords provided by Muneer Abidi, 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:
Layout table for MeSH terms
Lymphoma
Breast Neoplasms
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
 Nausea
Vomiting
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
Vascular Diseases
Cardiovascular Diseases