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 Malignant Melanoma
The vaccine will be made by mixing two kinds of cells: 1) some of the patient's own
malignant melanoma cells which were removed by surgery and then processed in the Cell
Therapy Laboratory, and 2) experimental "bystander" cells. All the cells in the vaccine
will be treated with high-dose X-rays to make sure that none of them grow and cause more
cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically
changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted
into them. These changes are designed to help boost the patient's immune system to better
fight the cancer in their body.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Partial Response
Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Average of 14 months
Sophie Dessureault, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|