Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
This trial is active, not recruiting.
|Treatments||cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, autologous tumor cell-based vaccine, il-2|
|Sponsor||H. Lee Moffitt Cancer Center and Research Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||July 2004|
|End date||October 2012|
|Trial size||43 participants|
|Trial identifier||NCT00101101, 0406-654, MCC-13840|
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 blood cells to kill cancer cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination chemotherapy may be a more effective treatment for mantle cell lymphoma.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II, stage III, or stage IV mantle cell lymphoma.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Rate of Immunological Response to Vaccination
time frame: 4 months per participant
Occurrence of Related Serious Adverse Events (SAEs)
time frame: 4 months per participant
Median Event Free Survival (EFS)
time frame: 18 months
Male or female participants at least 18 years old.
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
|Official title||A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma|
|Principal investigator||Sophie Dessureault, M.D., Ph.D.|
|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 completing chemotherapy, and included computed tomography (CT) scan, bone marrow biopsy, endoscopy, and colonoscopy. Minimal residual disease (MRD) was assessed qualitatively on bone marrow specimens using polymerase chain reaction (PCR) with standardized primers for evaluation for B-cell receptor gene rearrangement. Responses were defined according to revised Cheson criteria. Patients with successful lymph node harvest who had obtained complete or partial response could proceed to bystander vaccination. The GM.CD40L bystander vaccine administered intradermally into the bilateral axillary and inguinal nodal basins via eight separate injections (0.125 ml / injection). Low dose IL-2 (0.5 x 10^6 units) was given subcutaneously twice daily for 14 days following vaccination. Patients were restaged with CT and/or CT/PET and bone marrow biopsy every 6 months, beginning from the last date of chemotherapy. Follow-up bone marrow biopsy evaluation included an assessment for MRD as described above. Patients without disease progression or toxicity attributable to the vaccine were eligible for 4 monthly booster vaccines at 12 months and 24 months.|
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