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

NCT ID: NCT00226473

Last Updated: 2006-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-09-30

Brief Summary

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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%.

Detailed Description

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Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cisplatin, Vindesine, Dacarbazine (drugs)

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermatologic Cooperative Oncology Group

OTHER

Sponsor Role lead

Principal Investigators

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Jens Ulrich, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany

Axel Hauschild, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany

Peter Mohr, MD

Role: STUDY_DIRECTOR

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

Locations

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

Mannheim, Baden-Wurttemberg, Germany

Site Status RECRUITING

Dept. of Dermatology, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Dept. of Dermatology, University of Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Dept. of Dermatology, Medical Center Buxtehude

Buxtehude, Lower Saxony, Germany

Site Status RECRUITING

Dept. of Dermatology, Hildesheim

Hildesheim, Lower Saxony, Germany

Site Status RECRUITING

Dept. of. Dermatology, University of Saarland, Homburg

Homburg, Saaland, Germany

Site Status RECRUITING

Dept. of Dermatology, University Otto von Guericke

Magdeburg, Saxony-Anhalt, Germany

Site Status RECRUITING

Dept. of Dermatology, University of Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

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

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Dept. of Dermatology, Charité Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Dept. of Dermatology, Vivantes Clinics

Berlin, State of Berlin, Germany

Site Status RECRUITING

Dept. of Dermatology, Helios Clinic Erfurt

Erfurt, Thuringia, Germany

Site Status RECRUITING

Dept. of Dermatology, University of Jena

Jena, Thuringia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jens Ulrich, MD

Role: CONTACT

[email protected]
+49-391-6715428

Facility Contacts

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Dirk Schadendorf, MD

Role: primary

[email protected]
+49-621-3832127

Claus Garbe, MD

Role: primary

[email protected]
+49-7071-2980872

Konstanze Spieth, MD

Role: primary

[email protected]
+49-69-6301-5311

Peter Mohr, MD

Role: primary

[email protected]
+49-4161-7036297

Michael Tronnier, MD

Role: primary

+49-05121-894821

Wolfgang Tilgen, MD

Role: primary

[email protected]
+49-6841-3800

Jens Ulrich, MD

Role: primary

[email protected]
+49-391-6715428

Vassiliki Bekou, MD

Role: backup

[email protected]
+49-391-6715264

Axel Hauschild, MD

Role: primary

[email protected]
+49-431-596-1613

Sven Krengel, MD

Role: primary

[email protected]
+49-451-5002517

Uwe Trefzer, MD

Role: primary

[email protected]
+49-30-450518063

Maja Hofmann, MD

Role: backup

[email protected]
+49-30-450518063

Peter Kohl, MD

Role: primary

[email protected]
+49-30-60043601

Ruthild Linse, MD

Role: primary

+49-361-7814300

Martin Kaatz, MD

Role: primary

[email protected]
+49-3641-937302

References

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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.

Reference Type BACKGROUND
PMID: 10561349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10561229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10661773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9093725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11308250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10839290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10403690 (View on PubMed)

Other Identifiers

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ADO-MM-PAL8

Identifier Type: -

Identifier Source: org_study_id