Spots Global Cancer Trial Database for Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

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Trial Identification

Brief Title: Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

Official Title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells and Dendritic Cells as Active Specific Immunotherapy in Patients With Metastatic Melanoma

Study ID: NCT00948480

Conditions

Metastatic Melanoma

Interventions

Autologous tumor cells plus dendritic cells

GM-CSF

Study Description

Brief Summary: This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor \[GM-CSF\]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Detailed Description: 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.