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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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

Locations
Germany
Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim
Mannheim, Baden-Württemberg, Germany, D-68167
Dept. of Dermatology, University Hospital Tuebingen
Tuebingen, Baden-Württemberg, Germany, D-72076
Dept. of Dermatology, University of Frankfurt
Frankfurt, Hessen, Germany, D-60590
Dept. of Dermatology, Medical Center Buxtehude
Buxtehude, Niedersachsen, Germany, D-21641
Dept. of Dermatology, Hildesheim
Hildesheim, Niedersachsen, Germany, D-31134
Dept. of. Dermatology, University of Saarland, Homburg
Homburg, Saaland, Germany, D-66421
Dept. of Dermatology, University Otto von Guericke
Magdeburg, Saxony-Anhalt, Germany, D-39120
Dept. of Dermatology, University of Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, D-24105
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, D-23538
Dept. of Dermatology, Helios Clinic Erfurt
Erfurt, Thuringia, Germany, 99012
Dept. of Dermatology, University of Jena
Jena, Thuringia, Germany, D-07740
Dept. of Dermatology, Charité Berlin
Berlin, Germany, D-10098
Dept. of Dermatology, Vivantes Clinics
Berlin, Germany, D-12351
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
Vindesine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016