Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma. Determine the 2-year progression-free survival of patients treated with this regimen. Determine the safety of this regimen in these patients. Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 12 weeks for 2 years. PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.

Official Title
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An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: aldesleukin
* Biological: rituximab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes: Diffuse large cell lymphoma Diffuse mixed cell lymphoma Immunoblastic large cell lymphoma CD20+ disease Measurable progressive or refractory disease No primary CNS lymphoma or lymphomatous meningitis 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 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Lymphocyte count less than 20,000/mm^3 Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hemoglobin at least 9.5 g/dL Hepatic SGOT and SGPT no greater than 1.5 times upper limit of normal Bilirubin normal No liver disease Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following: Undetectable hepatitis C viral loads Biopsy showing no active disease Normal transaminases on at least 3 different occasions within the past year Renal Creatinine normal Cardiovascular No clinically significant cardiac dysfunction No myocardial infarction within the past 6 months No heart failure within the past 6 months Pulmonary No clinically significant pulmonary dysfunction Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No significant infections within the past 2 weeks (including pneumonia or bronchitis) No history of autoimmune disease No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No prior interleukin-2 No prior interferon (alfa, beta, or gamma) No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3 Chemotherapy More than 30 days since prior chemotherapy No concurrent anticancer chemotherapy Endocrine therapy More than 2 weeks since prior systemic steroids No concurrent systemic corticosteroids Radiotherapy More than 30 days since prior radiotherapy No concurrent radiotherapy Surgery More than 30 days since prior major surgery Other More than 30 days since other prior investigational drugs More than 30 days since prior immunosuppressive medications No concurrent immunosuppressive medications including the following: Cyclosporine Mycophenolate mofetil Tacrolimus Sirolimus

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: rituximab|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 large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma