rituximab, vaccine therapy, and gm-csf in treating patients with non-hodgkin's lymphoma

Conditions: Lymphoma

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.

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.

Eligibility 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

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