Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Favrille
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00258336
First received: November 22, 2005
Last updated: February 6, 2009
Last verified: August 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: rituximab Biological: sargramostim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival by Kaplan-Meier [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate (partial and complete response) at month 6 and any time [ Designated as safety issue: No ]
- Time-to-progression by Kaplan-Meier [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Immune response by cellular or humoral anti-idiotype response positive [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 56 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258336
Locations
| 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 | |
Sponsors and Collaborators
Favrille
Investigators
| Study Chair: | John F. Bender, PharmD | Favrille |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00258336 History of Changes |
| Other Study ID Numbers: | CDR0000449719, FAV-ID-70, FAV-ID-LYM-31 |
| Study First Received: | November 22, 2005 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV 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 stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Immunoglobulin Idiotypes |
Immunoglobulins Antibodies Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013