Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Dermatologic Cooperative Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dermatologic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00226473
First received: September 25, 2005
Last updated: June 20, 2006
Last verified: September 2005

September 25, 2005
June 20, 2006
September 2001
Not Provided
Overall survival
Same as current
Complete list of historical versions of study NCT00226473 on ClinicalTrials.gov Archive Site
  • Quality of life analysis
  • Objective tumor response rate in study arm B
  • Time to tumor progression
  • Cost analysis
Same as current
Not Provided
Not Provided
 
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
Drug: Cisplatin, Vindesine, Dacarbazine (drugs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2005
Not Provided

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)
Both
18 Years to 75 Years
No
Contact: Jens Ulrich, MD +49-391-6715428 jens.ulrich@medizin.uni-magdeburg.de
Germany
 
NCT00226473
ADO-MM-PAL8
Not Provided
Not Provided
Dermatologic Cooperative Oncology Group
Not Provided
Principal Investigator: Jens Ulrich, MD Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany
Principal Investigator: Axel Hauschild, MD Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany
Study Director: Peter Mohr, MD Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany
Dermatologic Cooperative Oncology Group
September 2005

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