NCT00090909

Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	dexamethasone
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-03-01
• First posted: 2004-09-08
• Last updated: 2013-01-08

Locations

1 site across 1 country: United States