Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's 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 effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Primary Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06. Secondary Determine the response rate and duration of response in patients treated with this regimen. Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen. Determine the time to progression in patients treated with this regimen. Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm). Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression. After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment. PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.

Official Title
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Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3 Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06 Meets 1 of the following criteria: Received salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since prior salvage therapy Did not receive salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06 No history of CNS lymphoma OR meningeal lymphomatosis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No history of congestive heart failure Pulmonary No history of compromised pulmonary function Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active bacterial, viral, or fungal infection No psychiatric disorder No other serious nonmalignant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior allogeneic transplantation* No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks) Chemotherapy No prior purine analogues* (e.g., fludarabine or cladribine) Endocrine therapy No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement) Radiotherapy Not specified Surgery Not specified Other Recovered from prior salvage therapy No prior or concurrent immunosuppressive therapy No prior investigational agents* No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study

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: autologous immunoglobulin idiotype-KLH conjugate vaccine|nan|
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by modified Cheson Criteria |  |  | 
| Duration of response by modified Cheson Criteria |  |  | 
| Time to progression |  |  | 
| Response rate improvement |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma