Status:
COMPLETED
Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Lymphoma Research Foundation
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may stimulate the white bl...
Detailed Description
Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician. Evaluation for response was performed 1 month after completin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma
- Stage II, III, or IV disease
- Relapsed or de novo disease
- No symptomatic brain metastasis
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy
- Not specified
- Hematopoietic
- White blood count (WBC) \> 3,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hematocrit \> 25%
- Hemoglobin \> 8 g/dL
- Hepatic
- Bilirubin \< 2.0 mg/dL
- Renal
- Creatinine \< 2.0 mg/dL OR
- Creatinine clearance \> 60 mL/min
- Immunologic
- No serious ongoing infection
- No known HIV infection
- No other pre-existing immunodeficiency condition
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No other concurrent immunotherapy
- Chemotherapy
- More than 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- More than 4 weeks since prior steroids
- No concurrent corticosteroids except as replacement doses in patients who are hypoadrenal
- Radiotherapy
- More than 2 weeks since prior radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- No other concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00101101
Start Date
July 1 2004
End Date
June 14 2021
Last Update
August 22 2023
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497