NCT00671554

Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma

Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.

Detailed description

Chemotherapy and immunotherapy are the main therapies for metastatic melanoma with the hope of prolonging survival. The ideal immunotherapy would consist of the professional antigen-presenting cell, the dendritic cell, with the entire repertoire of tumor antigens inside. The best way to achieve this is by creating an autologous hybrid fusion cell of the dendritic cell and tumor cell. In this study, melanoma tumor tissue surgically removed from the patient will be disassociated into single cells, irradiated and fused to dendritic cells produced by culturing the patient's blood monocytes. Prior to the electrofusion procedure, the tumor cells are stained red and the dendritic cells are stained green. After fusion, the uniquely colored fused cells, or dendritomas, are separated from the unfused cells by use of a fluorescence activated cell sorter. This highly purified population is then divided into 4 doses containing 250,000 dendritomas each and frozen. Each dose is thawed, diluted to 1 milliliter (ml) with Sterile Saline for Injection containing 5 percent (%) human serum albumin and administered subcutaneously (SQ) over a lymph node bed to the patient once every 4 weeks. A separate injection of Bacillus Calmette-Guerin (BCG) is administered in the same area within 10 minutes of the dendritoma injection. The safety and efficacy of the therapy will be evaluated in 25 patients.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Melaxin (autologous dendritoma vaccine) and BCG	Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-05-05
• Last updated: 2014-06-04
• Results posted: 2014-06-04

Locations

1 site across 1 country: United States