NCT00948480

Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Hoag Memorial Hospital Presbyterian · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous tumor cells plus dendritic cells	A series of 8 vaccinations are administered over 6 months
DRUG	GM-CSF	500 mcg

Timeline

• Start date: 2000-10-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2009-07-29
• Last updated: 2016-07-15

Locations

1 site across 1 country: United States