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

Phase 2CompletedNCT00204594

University Hospital Tuebingen1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Melanoma

Interventions

rM28DRUG

autologous PBMCsDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Tuebingen, Department of dermatology

Tübingen, Germany

Outcomes

Primary Outcomes

toxicity

clinical response

Data from ClinicalTrials.gov

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