Phase I Study with non-viral jet-injection-genetransfer of a TNF-alpha expressing MIDGE-vector in cutaneous metastases of malignant melanoma
Phase 1
Recruiting
- Conditions
- C43Malignant melanoma of skin
- Registration Number
- DRKS00005723
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
malignant melanoma with cutaneous metastases
pretreated with DTIC
Exclusion Criteria
cerebral metastases
active infections
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy and safety of TNF-expression after MIDGE vector injection (histological and serum control), day 1,2,3,10 and 24<br>clinical parameters (RR, heart frequency, temperature)<br>lab results (TNF, vector DNA, blood count, liver and renal function, CRP, cytokine profiling)<br>histology (day 3)
- Secondary Outcome Measures
Name Time Method