Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00258336|
Recruitment Status : Unknown
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 24, 2005
Last Update Posted : January 10, 2014
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|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Masking:||None (Open Label)|
|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 :||August 2004|
|Estimated Primary Completion Date :||November 2009|
- Event-free survival by Kaplan-Meier
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258336
|United States, Tennessee|
|Sarah Cannon Cancer Center at Centennial Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Clinical Trials Office - Sarah Cannon Cancer Center at Centenn 615-329-7274|
|Study Chair:||John F. Bender, PharmD||Favrille|