Spots Global Cancer Trial Database for Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment

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Trial Identification

Brief Title: Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment

Official Title: A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory

Study ID: NCT00014209

Conditions

Lymphoma

Interventions

cisplatin

dexamethasone

gemcitabine hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.

Detailed Description: OBJECTIVES: * Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma. * Determine the qualitative and quantitative toxicity of this regimen in these two patient populations. OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma). Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this study within 4-10 months.