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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 28, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs