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

Phase 1

Completed

• Conditions: Malignant Melanoma
• Interventions: Drug: rM28; Drug: autologous PBMCs

• Registration Number: NCT00204594
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antibody	rM28	-
Antibody	autologous PBMCs	-

Primary Outcome Measures

Name	Time	Method
toxicity
clinical response

Trial Locations

Locations (1)

University of Tuebingen, Department of dermatology; 🇩🇪 Tuebingen, Germany