Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
This study has been completed.
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: January 2013
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.
Drug: autologous PBMCs
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Primary Outcome Measures:
- clinical response
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2007 (Final data collection date for primary outcome measure)
Drug: autologous PBMCs
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- malignant melanoma stage III/IV
- injectable soft tissue metastasis
- informed consent given
- Karnofsky >= 70%
- additional chemotherapeutical treatment
- systemic glucocorticoids
- brain metestasis
- other malignancies
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00204594
|University of Tuebingen, Department of dermatology
|Tuebingen, Germany, 72076 |
University Hospital Tuebingen
||Garbe Claus, Prof. Dr.
||Department of dermatology, university of tuebingen
||Gundram Jung, Prof. Dr.
||University of Tuebingen, Dept. of Immunology
No publications provided
||Thomas Eigentler, Study Coordinator, University Hospital Tuebingen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||January 15, 2013
||Germany: Ethics Commission
Keywords provided by University Hospital Tuebingen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 29, 2014
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs