Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma
Patients were stratified by whether they had no measurable disease [NMD] at the time of
treatment (usually because of surgical resection of metastases), or whether they had
objectively measurable disease (OMD) by physical examination or radiologic scans per
response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the
results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor
cells, event-free survival [death or disease progression], overall survival, and objective
tumor regression in patients who have measurable disease at the time vaccine therapy was
initiated. This study was activated in the fall of 2000, and closed to accrual in June
2007.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
event-free survival [death or disease progression]
5.5 years after treatment initation
No
Robert O Dillman, MD
Principal Investigator
Hoag Memorial Hospital Presbyterian
United States: Food and Drug Administration
NCT00012064
NCT00948480
October 2000
September 2007
Name | Location |
---|---|
Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |