Phase I Study with non-viral jet-injection-genetransfer of a TNF-alpha expressing MIDGE-vector in cutaneous metastases of malignant melanoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005723

Enrollment

Registered

2014-02-17

Start date

2013-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C43

Interventions

Group 1: injection of the MIDGE-vector in cutaneous metastases of the malignant melanoma, the injection is a single-shot-treatment (1ml), after 3 days the metatasis will be resected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: malignant melanoma with cutaneous metastases pretreated with DTIC

Exclusion criteria

Exclusion criteria: cerebral metastases active infections

Design outcomes

Primary

Measure	Time frame
efficacy and safety of TNF-expression after MIDGE vector injection (histological and serum control), day 1,2,3,10 and 24 clinical parameters (RR, heart frequency, temperature) lab results (TNF, vector DNA, blood count, liver and renal function, CRP, cytokine profiling) histology (day 3)	—

Countries

Germany

Contacts

Public ContactFelix Kiecker

Charité Universitätsmedizin BerlinKlinik für Dermatologie

felix.kiecker@charite.de030450618233

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026