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| ID | Type | Description | Link |
|---|---|---|---|
| FAV-ID-70 | |||
| FAV-ID-LYM-31 |
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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:
OUTLINE: This is an open-label, multicenter study.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | |||
| rituximab | Biological | |||
| sargramostim | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival by Kaplan-Meier |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (partial and complete response) at month 6 and any time | ||
| Time-to-progression by Kaplan-Meier | ||
| Duration of response |
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DISEASE CHARACTERISTICS:
Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavIdâ„¢)
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
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Radiotherapy
Other
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| Name | Affiliation | Role |
|---|---|---|
| John F. Bender, PharmD | Favrille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Cancer Center at Centennial Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Immune response by cellular or humoral anti-idiotype response positive |
| Safety |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |