Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

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. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma. OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used: Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL) Stratum II:Recurrent aggressive NHL Stratum III: Refractory indolent NHL Stratum IV: Recurrent indolent NHL Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days. Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow transplantation after at least 2 courses. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum. The total number accrued will be 90-215 over a period of approximately 3 years.

Official Title
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Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma First relapse requires histologic confirmation of relapse No CNS metastases No lymphomatous meningitis Measurable disease PATIENT CHARACTERISTICS: Age: 15-75 Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Unless due to lymphoma: Platelet count at least 100,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Baseline calcium less than 12 mg/dL Cardiovascular: No myocardial infarction within 6 months No congestive heart failure requiring therapy Other: No history of seizures No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg) No other concurrent severe disease No uncontrolled infection HIV negative No psychoses No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years Not pregnant or lactating Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: No more than 2 prior chemotherapy regimens for treatment of lymphoma No prior irinotecan, topotecan or aminocamptothecin At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy) Surgery: Not specified Other: No phenytoin, phenobarbital, or other antiepileptic prophylaxis

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 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: irinotecan 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 diffuse small cleaved cell lymphoma, Waldenström macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma