Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00104819
- Lead Sponsor
- Favrille
- Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make 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 and may stimulate the immune system in different ways and stop cancer cells from growing.
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
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
- Secondary Outcome Measures
Name Time Method Response rate by modified Cheson Criteria Duration of response by modified Cheson Criteria Time to progression Response rate improvement
Trial Locations
- Locations (51)
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
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