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

Primary Purpose

Malignant Melanoma

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

rM28

autologous PBMCs

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring mRNA, vaccination, melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Tuebingen, Department of dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antibody

Arm Description

Outcomes

Primary Outcome Measures

toxicity

clinical response

Secondary Outcome Measures

Full Information

NCT ID

NCT00204594

First Posted

September 13, 2005

Last Updated

January 15, 2013

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT00204594

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

Keywords

mRNA, vaccination, melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antibody

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

rM28

Intervention Type

Drug

Intervention Name(s)

autologous PBMCs

Primary Outcome Measure Information:

Title

toxicity

Title

clinical response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Garbe Claus, Prof. Dr.

Organizational Affiliation

Department of dermatology, university of tuebingen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gundram Jung, Prof. Dr.

Organizational Affiliation

University of Tuebingen, Dept. of Immunology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Tuebingen, Department of dermatology

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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