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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226473
Recruitment Status : Unknown
Verified September 2005 by Dermatologic Cooperative Oncology Group.
Recruitment status was:  Recruiting
First Posted : September 27, 2005
Last Update Posted : June 21, 2006
Information provided by:
Dermatologic Cooperative Oncology Group

Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: Cisplatin, Vindesine, Dacarbazine (drugs) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Study Start Date : September 2001
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Dacarbazine

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Quality of life analysis
  2. Objective tumor response rate in study arm B
  3. Time to tumor progression
  4. Cost analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226473

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Contact: Jens Ulrich, MD +49-391-6715428

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Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim Recruiting
Mannheim, Baden-Württemberg, Germany, D-68167
Contact: Dirk Schadendorf, MD    +49-621-3832127   
Principal Investigator: Dirk Schadendorf, MD         
Dept. of Dermatology, University Hospital Tuebingen Recruiting
Tuebingen, Baden-Württemberg, Germany, D-72076
Contact: Claus Garbe, MD    +49-7071-2980872   
Principal Investigator: Claus Garbe, MD         
Dept. of Dermatology, University of Frankfurt Recruiting
Frankfurt, Hessen, Germany, D-60590
Contact: Konstanze Spieth, MD    +49-69-6301-5311   
Principal Investigator: Konstanze Spieth, MD         
Dept. of Dermatology, Medical Center Buxtehude Recruiting
Buxtehude, Niedersachsen, Germany, D-21641
Contact: Peter Mohr, MD    +49-4161-7036297   
Principal Investigator: Peter Mohr, MD         
Dept. of Dermatology, Hildesheim Recruiting
Hildesheim, Niedersachsen, Germany, D-31134
Contact: Michael Tronnier, MD    +49-05121-894821      
Principal Investigator: Michael Tronnier, MD         
Dept. of. Dermatology, University of Saarland, Homburg Recruiting
Homburg, Saaland, Germany, D-66421
Contact: Wolfgang Tilgen, MD    +49-6841-3800   
Sub-Investigator: Dorothea Tadler, MD         
Dept. of Dermatology, University Otto von Guericke Recruiting
Magdeburg, Saxony-Anhalt, Germany, D-39120
Contact: Jens Ulrich, MD    +49-391-6715428   
Contact: Vassiliki Bekou, MD    +49-391-6715264   
Sub-Investigator: Vassiliki Bekou, MD         
Dept. of Dermatology, University of Schleswig-Holstein Recruiting
Kiel, Schleswig-Holstein, Germany, D-24105
Contact: Axel Hauschild, MD    +49-431-596-1613   
Principal Investigator: Axel Hauschild, MD         
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, D-23538
Contact: Sven Krengel, MD    +49-451-5002517   
Principal Investigator: Sven Krengel, MD         
Dept. of Dermatology, Helios Clinic Erfurt Recruiting
Erfurt, Thuringia, Germany, 99012
Contact: Ruthild Linse, MD    +49-361-7814300      
Principal Investigator: Ruthild Linse, MD         
Sub-Investigator: Yvonne Kellner, MD         
Dept. of Dermatology, University of Jena Recruiting
Jena, Thuringia, Germany, D-07740
Contact: Martin Kaatz, MD    +49-3641-937302   
Principal Investigator: Martin Kaatz, MD         
Dept. of Dermatology, Charité Berlin Recruiting
Berlin, Germany, D-10098
Contact: Uwe Trefzer, MD    +49-30-450518063   
Contact: Maja Hofmann, MD    +49-30-450518063   
Principal Investigator: Uwe Trefzer, MD         
Dept. of Dermatology, Vivantes Clinics Recruiting
Berlin, Germany, D-12351
Contact: Peter Kohl, MD    +49-30-60043601   
Principal Investigator: Peter Kohl, MD         
Sponsors and Collaborators
Dermatologic Cooperative Oncology Group
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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

Layout table for additonal information Identifier: NCT00226473    
Other Study ID Numbers: ADO-MM-PAL8
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: June 21, 2006
Last Verified: September 2005
Keywords provided by Dermatologic Cooperative Oncology Group:
malignant Melanoma
standard palliative care
best supportive care
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators