Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III, Stage IV, or Recurrent Follicular Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for follicular lymphoma . PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have stage III, stage IV, or recurrent follicular lymphoma.

Detailed Description
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OBJECTIVES: Assess the safety of immunotherapy with autologous tumor cell vaccine and interleukin-2 in patients with stage III, IV, or recurrent follicular lymphoma. Determine the clinical response of patients treated with this regimen. Assess the immune response of patients treated with this vaccine. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (no prior biologic therapy or chemotherapy for lymphoma vs prior prednisone, doxorubicin, cyclophosphamide, and etoposide (PACE) chemotherapy). Patients without prior therapy are further stratified according to accessibility of lymph nodes (easily accessible (stratum Ia) vs not easily accessible (stratum Ib)). All patients undergo lymph node biopsy to obtain tissue for vaccine manufacture. Treatment begins approximately 1 month after biopsy. Stratum Ia: Patients receive autologous tumor cell vaccine and interleukin-2 (IL-2) intranodally and subcutaneously (SC) on day 1. Stratum Ib and stratum II: Patients receive autologous tumor cell vaccine and IL-2 SC on day 1. Treatment in each stratum continues every 4 weeks for a maximum of 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 and 4 months, every 3 months for 1 year, and every 6 months thereafter until relapse or progression of disease. PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study within 1.5-2 years.

Official Title
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Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: aldesleukin
* Biological: autologous tumor cell vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven follicular center cell lymphoma with surface immunoglobulin (Ig) M, G, or A phenotype Grade I (follicular small cleaved cell) Grade II (follicular mixed small and large cell) Grade III (follicular large cell) Stage III, IV, or recurrent disease Previously untreated with chemotherapy or monoclonal antibody therapy OR Recurrent, residual disease or progressive disease after prior prednisone, doxorubicin, cyclophosphamide, and etoposide (PACE) chemotherapy Peripheral lymph node of at least 2 cm and accessible for biopsy/harvest No primary or secondary CNS lymphoma Must not have any of the following: Rapidly progressing lymphadenopathy Bone marrow failure secondary to lymphoma B symptoms Neurovascular or organ compromise secondary to lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 1 year Hematopoietic: Not specified Hepatic: ALT/AST no greater than 3.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL unless secondary to Gilbert's disease Hepatitis B surface antigen negative Hepatitis C antibody negative Renal: Creatinine no greater than 1.5 mg/dL Other: HIV negative No active infection No other prior or concurrent malignancy except curatively treated squamous cell or basal cell skin cancer or effectively treated carcinoma in situ of the cervix No medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No other concurrent biologic therapy for lymphoma Chemotherapy: See Disease Characteristics At least 3 months since prior PACE chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior steroid treatment Less than 2 months of prior prednisone No concurrent endocrine therapy for lymphoma Radiotherapy: Prior radiotherapy to no more than 1 site allowed At least 2 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Lymph node biopsy performed within past month

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: autologous tumor cell vaccine|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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stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma