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

NCT ID: NCT00204594

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Malignant Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibody

Group Type EXPERIMENTAL

rM28

Intervention Type DRUG

autologous PBMCs

Intervention Type DRUG

Interventions

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rM28

Intervention Type DRUG

autologous PBMCs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Thomas Eigentler

Study Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garbe Claus, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of dermatology, university of tuebingen

Gundram Jung, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Tuebingen, Dept. of Immunology

Locations

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University of Tuebingen, Department of dermatology

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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rM28-001

Identifier Type: -

Identifier Source: org_study_id

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