Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
NCT ID: NCT00104819
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
PHASE2
238 participants
INTERVENTIONAL
2004-09-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
Detailed Description
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Primary
* Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06.
Secondary
* Determine the response rate and duration of response in patients treated with this regimen.
* Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
* Determine the time to progression in patients treated with this regimen.
* Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).
Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.
After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.
PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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autologous immunoglobulin idiotype-KLH conjugate vaccine
sargramostim
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
* Grade 1, 2, or 3
* Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06
* Meets 1 of the following criteria:
* Received salvage therapy after completion of protocol FAV-ID-06
* At least 4 weeks, but no more than 4 months, since prior salvage therapy
* Did not receive salvage therapy after completion of protocol FAV-ID-06
* At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06
* No history of CNS lymphoma OR meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No history of congestive heart failure
Pulmonary
* No history of compromised pulmonary function
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active bacterial, viral, or fungal infection
* No psychiatric disorder
* No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior allogeneic transplantation\*
* No prior rituximab regimen\* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m\^2 IV weekly for 4 weeks)
Chemotherapy
* No prior purine analogues\* (e.g., fludarabine or cladribine)
Endocrine therapy
* No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Recovered from prior salvage therapy
* No prior or concurrent immunosuppressive therapy
* No prior investigational agents\*
* No other concurrent antilymphoma therapy NOTE: \*As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Favrille
INDUSTRY
Principal Investigators
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John F. Bender, PharmD
Role: STUDY_CHAIR
Favrille
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, 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
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 Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center
Stanford, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States
Lombardi Comprehensive 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
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Kootenai Cancer Center - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 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 - Saint Louis
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
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, 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
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Mid Dakota Clinic, PC
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
Case Comprehensive Cancer Center
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 Medical Center
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
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
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
Cancer Care Centers of South Texas - Medical Center
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 Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CDR0000415573
Identifier Type: REGISTRY
Identifier Source: secondary_id
CWRU-FVID-2404
Identifier Type: -
Identifier Source: secondary_id
CWRU-100415
Identifier Type: -
Identifier Source: secondary_id
CASE-2404
Identifier Type: -
Identifier Source: secondary_id
FAV-WIRB-20041124
Identifier Type: -
Identifier Source: secondary_id
FAV-ID-09
Identifier Type: -
Identifier Source: org_study_id