Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
18 Years
75 Years
Both
Malignant Melanoma
Trial Information
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of
the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic
melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops
of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days
with dose escalation.
Inclusion Criteria:
- malignant melanoma stage III/IV
- injectable soft tissue metastasis
- informed consent given
- Karnofsky >= 70%
Exclusion Criteria:
- additional chemotherapeutical treatment
- systemic glucocorticoids
- brain metestasis
- other malignancies
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
toxicity
Principal Investigator
Garbe Claus, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of dermatology, university of tuebingen
Authority:
Germany: Ethics Commission
Study ID:
rM28-001
NCT ID:
NCT00204594
Start Date:
October 2005
Completion Date:
December 2007
Related Keywords:
- Malignant Melanoma
- mRNA
- vaccination
- melanoma
- Melanoma
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