Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.
|Lymphoma||Drug: cisplatin Drug: dexamethasone Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma|
|Study Start Date:||June 2003|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
- Determine the response rate and maximum response in patients with relapsed or refractory Hodgkin's lymphoma treated with gemcitabine, cisplatin, and dexamethasone.
- Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gemcitabine IV over 1 hour on days 1 and 8, cisplatin IV over 3 hours on day 1, and oral dexamethasone twice daily on days 1-4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090909
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1678|
|Study Chair:||Christos E. Emmanouilides, MD||Jonsson Comprehensive Cancer Center|