Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Hematology, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | October 2004 |
| End Date: | February 2012 |
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.
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.
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.
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
We found this trial at
1
site
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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