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

September 13, 2005
January 15, 2013
October 2005
December 2007   (final data collection date for primary outcome measure)
  • toxicity
  • clinical response
Same as current
Complete list of historical versions of study NCT00204594 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: rM28
  • Drug: autologous PBMCs
Experimental: Antibody
Interventions:
  • Drug: rM28
  • Drug: autologous PBMCs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204594
rM28-001
No
Thomas Eigentler, University Hospital Tuebingen
University Hospital Tuebingen
Not Provided
Principal Investigator: Garbe Claus, Prof. Dr. Department of dermatology, university of tuebingen
Principal Investigator: Gundram Jung, Prof. Dr. University of Tuebingen, Dept. of Immunology
University Hospital Tuebingen
January 2013

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