Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description
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OBJECTIVES: I. Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma. II. Determine the treatment-related toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive). Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.

Official Title
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A Phase II Study of Oxaliplatin in Relapsed and Refractory Non-Hodgkin's Lymphoma

Conditions
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Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype Indolent Follicular small cleaved cell Follicular mixed cell Small lymphocytic Mucosa-associated lymphoid tissue (MALT) Monocytoid B-cell Waldenstrom's macroglobulinemia Aggressive Follicular large cell Diffuse large cell Immunoblastic Mantle cell Ki-1+ NHL Peripheral T-cell Angiocentric and angioimmunoblastic Transformed lymphoma Bidimensionally measurable disease No more than 3 prior treatment regimens as follows: Primary radiotherapy is 1 regimen Combined therapy with radiotherapy and chemotherapy is 1 regimen Alternating therapy is 1 regimen No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 50-100% WBC count at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No neuropathy greater than grade 1 No history of allergy to platinum compounds or antiemetics No uncontrolled illness No active infection Not pregnant or nursing Fertile patients must use effective contraception No concurrent colony-stimulating factors during first course of therapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy No other concurrent investigational drugs No concurrent antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (oxaliplatin)<br>Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. | Drug: oxaliplatin<br>* Given IV<br>* Other names: L-OHP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Using a Simon's two-stage model. | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response | Analyzed using the Kaplan-Meier method. | Up to 6 years |