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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
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
 Drug: rM28
Drug: autologous PBMCs
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • toxicity
  • clinical response

Enrollment: 1
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibody Drug: rM28 Drug: autologous PBMCs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204594

Locations
Germany
University of Tuebingen, Department of dermatology
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Garbe Claus, Prof. Dr. Department of dermatology, university of tuebingen
Principal Investigator: Gundram Jung, Prof. Dr. University of Tuebingen, Dept. of Immunology
  More Information

No publications provided

Responsible Party: Thomas Eigentler, Study Coordinator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00204594     History of Changes
Other Study ID Numbers: rM28-001
Study First Received: September 13, 2005
Last Updated: January 15, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
mRNA
vaccination
melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013