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

NCT00226473 | Unknown Phase 4

• 1 other identifier: ADO-MM-PAL8
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

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%.

Conditions

Metastatic Melanoma

Keywords

malignant Melanoma; Chemotherapy; Metastasis; standard palliative care; best supportive care

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• Quality of life analysis

• Objective tumor response rate in study arm B

• Time to tumor progression

• Cost analysis

Interventions

Cisplatin, Vindesine, Dacarbazine (drugs) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histological diagnosis of metastatic melanoma (stage IV)
• progressive disease after first-line chemotherapy or immuno-chemotherapy
• Karnofsky-index \> 60%
• informed consent

You may not qualify if:

• Uvea melanoma
• another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
• severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

Sponsors & Collaborators

• Dermatologic Cooperative Oncology Group: lead

Study Sites (13)

Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim

Mannheim, Baden-Wurttemberg, D-68167, Germany

RECRUITING

Dept. of Dermatology, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

RECRUITING

Dept. of Dermatology, University of Frankfurt

Frankfurt am Main, Hesse, D-60590, Germany

RECRUITING

Dept. of Dermatology, Medical Center Buxtehude

Buxtehude, Lower Saxony, D-21641, Germany

RECRUITING

Dept. of Dermatology, Hildesheim

Hildesheim, Lower Saxony, D-31134, Germany

RECRUITING

Dept. of. Dermatology, University of Saarland, Homburg

Homburg, Saaland, D-66421, Germany

RECRUITING

Dept. of Dermatology, University Otto von Guericke

Magdeburg, Saxony-Anhalt, D-39120, Germany

RECRUITING

Dept. of Dermatology, University of Schleswig-Holstein

Kiel, Schleswig-Holstein, D-24105, Germany

RECRUITING

Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, D-23538, Germany

RECRUITING

Dept. of Dermatology, Charité Berlin

Berlin, State of Berlin, D-10098, Germany

RECRUITING

Dept. of Dermatology, Vivantes Clinics

Berlin, State of Berlin, D-12351, Germany

RECRUITING

Dept. of Dermatology, Helios Clinic Erfurt

Erfurt, Thuringia, 99012, Germany

RECRUITING

Dept. of Dermatology, University of Jena

Jena, Thuringia, D-07740, Germany

RECRUITING

Related Publications (7)

• Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745.

  PMID: 10561349 BACKGROUND

• Creagan ET, Suman VJ, Dalton RJ, Pitot HC, Long HJ, Veeder MH, Vukov AM, Rowland KM, Krook JE, Michalak JC. Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma. J Clin Oncol. 1999 Jun;17(6):1884-90. doi: 10.1200/JCO.1999.17.6.1884.

  PMID: 10561229 BACKGROUND

• Cure H, Souteyrand P, Ouabdesselam R, Roche H, Ravaud A, D'incan M, Viens P, Fargeot P, Lentz MA, Fumoleau P, Hanauske A, Chollet P. Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group. Melanoma Res. 1999 Dec;9(6):607-10. doi: 10.1097/00008390-199912000-00011.

  PMID: 10661773 BACKGROUND

• Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668.

  PMID: 9093725 BACKGROUND

• Hauschild A, Garbe C, Stolz W, Ellwanger U, Seiter S, Dummer R, Ugurel S, Sebastian G, Nashan D, Linse R, Achtelik W, Mohr P, Kaufmann R, Fey M, Ulrich J, Tilgen W. Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: a randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). Br J Cancer. 2001 Apr 20;84(8):1036-42. doi: 10.1054/bjoc.2001.1731.

  PMID: 11308250 BACKGROUND

• Propper DJ, Levitt NC, O'Byrne K, Braybrooke JP, Talbot DC, Ganesan TS, Thompson CH, Rajagopalan B, Littlewood TJ, Dixon RM, Harris AL. Phase II study of the oxygen saturation curve left shifting agent BW12C in combination with the hypoxia activated drug mitomycin C in advanced colorectal cancer. Br J Cancer. 2000 Jun;82(11):1776-82. doi: 10.1054/bjoc.2000.1138.

  PMID: 10839290 BACKGROUND

• Thongprasert S, Sanguanmitra P, Juthapan W, Clinch J. Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy. Lung Cancer. 1999 Apr;24(1):17-24. doi: 10.1016/s0169-5002(99)00017-3.

  PMID: 10403690 BACKGROUND

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Cisplatin; Vindesine; Dacarbazine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Peter Mohr, MD

  Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany

  STUDY DIRECTOR

Central Study Contacts

Jens Ulrich, MD

CONTACT

+49-391-6715428; jens.ulrich@medizin.uni-magdeburg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2005
• First Posted: September 27, 2005
• Study Start: September 1, 2001
• Study Completion: September 1, 2005
• Last Updated: June 21, 2006

Record last verified: 2005-09

Locations

DE (13)