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
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
- 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
Interventions
- DRUG
-
Aprepitant
Aprepitant 80mg once daily in the morning on days 2 and 3
- DRUG
-
Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
- DRUG
-
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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