- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258336
Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Cancer Center at Centennial Medical Center
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Contact:
- Clinical Trials Office - Sarah Cannon Cancer Center at Centenn
- Phone Number: 615-329-7274
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Event-free survival by Kaplan-Meier
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety
|
Duration of response
|
Overall response rate (partial and complete response) at month 6 and any time
|
Time-to-progression by Kaplan-Meier
|
Immune response by cellular or humoral anti-idiotype response positive
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: John F. Bender, PharmD, Favrille
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent 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
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- Immunoglobulin Idiotypes
- Rituximab
- Sargramostim
Other Study ID Numbers
- CDR0000449719
- FAV-ID-70
- FAV-ID-LYM-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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