Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
NCT00257465 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2015-12-03
Summary
The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.
Conditions
Interventions
- BIOLOGICAL
-
Autologous, DNP-modified vaccine (M-Vax)
5.0, 2.5, 0.5, or 0 cells
- BIOLOGICAL
-
Autologous, DNP-Modified Melanoma Vaccine
5 million cells
- BIOLOGICAL
-
Autologous, DNP-Modified Vaccine
2.5 million cells
- BIOLOGICAL
-
Autologous, DNP-Modified Vaccine
0.5 million cells
- BIOLOGICAL
-
Autologous, DNP-Modified Vaccine
0 cells
Sponsors & Collaborators
-
AVAX Technologies
lead INDUSTRY
Principal Investigators
-
David Berd, MD · AVAX Technologies
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2008-06-30
- Completion
- 2008-06-30
Countries
- United States
Study Locations
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