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NCT00204594 Clinical Trial

Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Malignant Melanoma Clinical Trial

Official title:
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204594
Other study ID # rM28-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated January 15, 2013
Start date October 2005
Est. completion date December 2007

Study information
Verified date January 2013
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rM28

• autologous PBMCs

Locations
Country Name City State
Germany University of Tuebingen, Department of dermatology Tuebingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary toxicity
Primary clinical response
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