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
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: Cisplatin, Vindesine, Dacarbazine (drugs)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dermatologic Cooperative Oncology Group:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Quality of life analysis
  • Objective tumor response rate in study arm B
  • Time to tumor progression
  • Cost analysis

Estimated Enrollment: 200
Study Start Date: September 2001
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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: NCT00226473

Contacts
Contact: Jens Ulrich, MD +49-391-6715428 jens.ulrich@medizin.uni-magdeburg.de

Locations
Germany
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    d.schadendorf@dkfz.de   
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    studienzentrum-derm-onko@med.uni-tuebingen.de   
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    konstanze.spieth@kgu.de   
Principal Investigator: Konstanze Spieth, MD         
Dept. of Dermatology, Medical Center Buxtehude Recruiting
Buxtehude, Niedersachsen, Germany, D-21641
Contact: Peter Mohr, MD    +49-4161-7036297    mohrpe@cs.com   
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    hawtil@med-rz-sb.de   
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    jens.ulrich@medizin.uni-magdeburg.de   
Contact: Vassiliki Bekou, MD    +49-391-6715264    vassiliki.bekou@medizin.uni-magdeburg.de   
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    ahauschild@dermatology.uni.kiel.de   
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    svenkrengel@gm.net   
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    kaatz@derma.uni-jena.de   
Principal Investigator: Martin Kaatz, MD         
Dept. of Dermatology, Charité Berlin Recruiting
Berlin, Germany, D-10098
Contact: Uwe Trefzer, MD    +49-30-450518063    uwe.trefzer@charite.de   
Contact: Maja Hofmann, MD    +49-30-450518063    maja.hofmann@charite.de   
Principal Investigator: Uwe Trefzer, MD         
Dept. of Dermatology, Vivantes Clinics Recruiting
Berlin, Germany, D-12351
Contact: Peter Kohl, MD    +49-30-60043601    p.kohl@vivantes.de   
Principal Investigator: Peter Kohl, MD         
Sponsors and Collaborators
Dermatologic Cooperative Oncology Group
Investigators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00226473     History of Changes
Other Study ID Numbers: ADO-MM-PAL8
Study First Received: September 25, 2005
Last Updated: June 20, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dermatologic Cooperative Oncology Group:
malignant Melanoma
Chemotherapy
Metastasis
standard palliative care
best supportive care

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Cisplatin
Dacarbazine
Vindesine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 27, 2014