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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204594
First Posted: September 20, 2005
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Thomas Eigentler, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas Eigentler, Study Coordinator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00204594     History of Changes
Other Study ID Numbers: rM28-001
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Thomas Eigentler, 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
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs