Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma

Sponsor

Favrille (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00258336

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: rituximab Biological: sargramostim	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma

Study Start Date :

Aug 1, 2004

Anticipated Primary Completion Date :

Nov 1, 2009

Outcome Measures

Primary Outcome Measures

Event-free survival by Kaplan-Meier []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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