Lymphoma
Conditions
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma
Brief summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help 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. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of response rate (partial and complete) and event-free survival, in patients with indolent B-cell non-Hodgkin's lymphoma. * Determine the safety of this regimen in these patients. * Evaluate development of an immune response in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. * Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks. Patients are evaluated for response at month 3. Patients with responding or stable disease proceed to maintenance therapy. Patients with progressive disease are removed from study. * Maintenance therapy: Patients receive rituximab as in induction therapy in months 7, 13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with continued response after completing 2 years of therapy may continue to receive FavId™ and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
Interventions
BIOLOGICALrituximab
BIOLOGICALsargramostim
Sponsors
Favrille
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes: * Grade 1 or 2 follicular lymphoma * Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) * Measurable or evaluable disease after node biopsy * No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma * No CNS involvement with lymphoma PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2 times upper limit of normal * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * HIV negative * No other medical or psychiatric disease that would preclude study compliance * No other malignancy (active or treated) within the past 5 years PRIOR CONCURRENT THERAPY: Radiotherapy * Prior local radiotherapy allowed Other * No other prior anticancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival by Kaplan-Meier | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (partial and complete response) at month 6 and any time | — |
| Time-to-progression by Kaplan-Meier | — |
| Duration of response | — |
| Immune response by cellular or humoral anti-idiotype response positive | — |
| Safety | — |
Countries
United States
Outcome results
None listed