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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: cisplatin
* Drug: dexamethasone
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed Hodgkin's disease OR Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL) No prior diagnosis of low-grade NHL No histologic evidence of transformation from indolent to aggressive histology Bidimensionally measurable disease that is clinically or radiologically documented Bone lesions not considered bidimensionally measurable Lymph nodes at least 1.5 cm by 1.5 cm OR Other non-nodal lesions at least 1 cm by 1 cm Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin) No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine less than 1.6 mg/dL Cardiovascular: No significant cardiac dysfunction or cardiovascular disease Other: HIV negative No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix No other serious illness or medical condition that would preclude study No active uncontrolled bacterial, fungal, or viral infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation No concurrent monoclonal antibody therapy No concurrent growth factors during the first course of study Chemotherapy: See Disease Characteristics At least 4 weeks since prior IV chemotherapy No prior cisplatin or gemcitabine No prior high-dose chemotherapy No other concurrent cytotoxic therapy Endocrine therapy: No concurrent corticosteroids, except for physiologic replacement Radiotherapy: No prior radiotherapy to more than 25% of functioning bone marrow At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent anti-cancer therapy or experimental therapy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: dexamethasone|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult Hodgkin lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma