Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
NCT00671554 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2014-06-04
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Oncolix, Inc.
collaborator INDUSTRY -
Prisma Health-Upstate
lead OTHER
Principal Investigators
-
Thomas E Wagner, PhD · Greenville Hospital System
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2009-02-28
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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