NCT00204607CompletedPhase 1
Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial
University Hospital Tuebingen2 sites in 1 country20 target enrollmentStarted: July 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- toxicity
Study Overview
Brief Summary
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen
Detailed Description
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stage III/IV
- •fresh frozen tumor-tissue
- •age 18-75
- •informed consent given
- •Karnofsky >= 70%
Exclusion Criteria
- •systemic glucocorticoids
- •brain metestasis
- •other malignancies
Outcomes
Primary Outcomes
toxicity
immune response
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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