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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Thomas Eigentler, University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT00204594

First received: September 13, 2005

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 15, 2013

Start Date ^ICMJE

October 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

toxicity
clinical response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00204594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Malignant Melanoma

Intervention ^ICMJE

Drug: rM28
Drug: autologous PBMCs

Study Arm (s)

Experimental: Antibody

Interventions:

Drug: rM28
Drug: autologous PBMCs

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00204594

Other Study ID Numbers ^ICMJE

rM28-001

Has Data Monitoring Committee

Responsible Party

Thomas Eigentler, University Hospital Tuebingen

Study Sponsor ^ICMJE

University Hospital Tuebingen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Garbe Claus, Prof. Dr.	Department of dermatology, university of tuebingen
Principal Investigator:	Gundram Jung, Prof. Dr.	University of Tuebingen, Dept. of Immunology

Information Provided By

University Hospital Tuebingen

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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