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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060164 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining rituximab with autologous vaccine therapy and sargramostim may cause a stronger immune response and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with autologous vaccine therapy and sargramostim in treating patients who have recurrent or refractory follicular B-cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: rituximab Biological: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma |
Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive rituximab IV once weekly for 4 weeks. Beginning at least 8 weeks later, patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine (Id-KLH) and sargramostim (GM-CSF) subcutaneously once monthly for a total of 6 months in the absence of disease progression or unacceptable toxicity.
Patients who achieve an objective response (complete response or partial response) or stable disease may continue to receive Id-KLH and GM-CSF every other month for a total of 6 doses and then every 3 months in the absence of disease progression.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet one of the following criteria for relapsed/refractory disease:
Relapsed after prior rituximab
No more than 2 prior treatment regimens
Measurable disease after node biopsy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No compromised pulmonary function that would preclude study participation, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000299533, CWRU-FVID-1402, FAV-ID-04 |
Study First Received: | May 6, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00060164 History of Changes |
Health Authority: | United States: Federal Government |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Immunoproliferative Disorders Immunologic Factors Immunoglobulin Idiotypes Rituximab Lymphoma, Follicular Follicular Lymphoma Recurrence Lymphoma, B-Cell |
Lymphatic Diseases Antibodies B-cell Lymphomas Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |