M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 12
- Primary Endpoint
- Immune response to patients' own melanoma cells
Study Overview
Brief 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.
Detailed Description
Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status
Exclusion Criteria
- •brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses
Outcomes
Primary Outcomes
Immune response to patients' own melanoma cells
Time Frame: 2 months
Secondary Outcomes
- Safety(9 months)