Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2004 |
Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma
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.
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.
- 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.
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
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