Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00089115
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
INTERVENTIONAL
2004-07-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.
Detailed Description
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Primary
* Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.
Secondary
* Compare response rate improvement in patients treated with these regimens.
* Compare overall complete response rate in patients treated with these regimens.
* Compare duration of response in patients treated with these regimens.
* Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior treatment (yes vs no) and response to rituximab during study (complete response \[CR\] or partial response \[PR\] vs stable disease \[SD\]).
All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of rituximab, patients are assessed for response. Patients with progressive disease are removed from the study and do not undergo randomization. Patients with a CR, PR, or SD are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
* Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4.
In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease. After the first 6 months, patients with a CR, PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for 1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease progression.
Patients are followed every 3 months for 2 years and then every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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autologous immunoglobulin idiotype-KLH conjugate vaccine
rituximab
sargramostim
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
* Grade 1, 2, or 3
* Meets 1 of the following criteria for treatment with rituximab:
* Treatment naïve
* Relapsed or refractory disease after prior chemotherapy
* Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
* Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
* Measurable or evaluable disease after tumor tissue procurement for vaccine production
* No more than 2 prior treatment regimens for NHL
* Single regimens include any of the following:
* Maintenance rituximab
* Rituximab administered once weekly for 8 courses
* Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab\* NOTE: \*CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
* No history of CNS lymphoma or meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 75,000/mm\^3 (unless related to bone marrow involvement by lymphoma)
* Hemoglobin ≥ 10g/dL
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No congestive heart failure
Pulmonary
* No compromised pulmonary function
Immunologic
* HIV negative
* No prior allergic response to GM-CSF
* No active bacterial, viral, or fungal infection
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric disorder that would preclude study participation
* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* See Chemotherapy
* At least 4 weeks since prior immunotherapy
* No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
* No prior autologous or allogeneic stem cell transplantation
* No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
* No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* More than 9 months since prior fludarabine
* More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone \[CVP\]/rituximab)
* No more than 6 total prior treatment courses with fludarabine
Endocrine therapy
* No concurrent steroids for allergic reaction to sargramostim (GM-CSF)
Radiotherapy
* See Biologic therapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since prior experimental therapy
* No concurrent systemic immunosuppressive therapy
* No other concurrent anti-lymphoma therapy
18 Years
ALL
No
Sponsors
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Favrille
INDUSTRY
Principal Investigators
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John F. Bender, PharmD
Role: STUDY_CHAIR
Favrille
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Sharp Memorial Hospital Cancer Center
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Center for Hematology-Oncology - Boca Raton
Boca Raton, Florida, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Beth Israel Medical Center - Philipps Ambulatory Care Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Kaiser Permanente Medical Office - Interstate Medical Office Central
Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center - Dallas
Dallas, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Cancer Care Network of South Texas
San Antonio, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Countries
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References
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Freedman A, Neelapu SS, Nichols C, Robertson MJ, Djulbegovic B, Winter JN, Bender JF, Gold DP, Ghalie RG, Stewart ME, Esquibel V, Hamlin P. Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma. J Clin Oncol. 2009 Jun 20;27(18):3036-43. doi: 10.1200/JCO.2008.19.8903. Epub 2009 May 4.
Other Identifiers
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CDR0000378046
Identifier Type: REGISTRY
Identifier Source: secondary_id
FAV-WIRB-20040335
Identifier Type: -
Identifier Source: secondary_id
CWRU-FVID-1404
Identifier Type: -
Identifier Source: secondary_id
FAV-ID-06
Identifier Type: -
Identifier Source: org_study_id