Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
Conditions
Lymphoma
Conditions: official terms
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: autologous immunoglobulin idiotype-KLH conjugate vaccine Type: Biological
Name: rituximab Type: Biological
Name: sargramostim Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Office - Sarah Cannon Cancer Center at Centenn - 615-329-7274
Start Date
August 2004
Sponsors
Favrille
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page