Status:
UNKNOWN
Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Favrille
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
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 (pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00258336
Start Date
August 1 2004
Last Update
January 10 2014
Active Locations (1)
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1
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States, 37203