Trial Information
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Inclusion Criteria:
- histological diagnosis of metastatic melanoma (stage IV)
- progressive disease after first-line chemotherapy or immuno-chemotherapy
- Karnofsky-index > 60%
- informed consent
Exclusion Criteria:
- Uvea melanoma
- another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
- severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Principal Investigator
Jens Ulrich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ADO-MM-PAL8
NCT ID:
NCT00226473
Start Date:
September 2001
Completion Date:
September 2005
Related Keywords:
- Metastatic Melanoma
- malignant Melanoma
- Chemotherapy
- Metastasis
- standard palliative care
- best supportive care
- Melanoma
- Neoplasm Metastasis