AzTrials
AzTrials

Metastatic MelanomaPhase 4NCT00226473

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

A Phase 4 study testing Cisplatin, Vindesine, Dacarbazine (drugs) in people with Metastatic Melanoma, run by Dermatologic Cooperative Oncology Group at 13 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Melanoma
What is being tested?
Cisplatin, Vindesine, Dacarbazine (drugs)
How many people
200 participants
Where
13 sitesGermany
Study dates
Sep 2001to Sep 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

Jens Ulrich, MD contact

+49-391-6715428

jens.ulrich@medizin.uni-magdeburg.de

13 sites in 1 country

Germany13 sites, 13 recruiting

  • Dept. of Dermatology, Charité Berlin

    Berlin, State of Berlin, D-10098

    Uwe Trefzer, MD, +49-30-450518063, uwe.trefzer@charite.de

    Maja Hofmann, MD, +49-30-450518063, maja.hofmann@charite.de

    Recruiting

  • Dept. of Dermatology, Vivantes Clinics

    Berlin, State of Berlin, D-12351

    Peter Kohl, MD, +49-30-60043601, p.kohl@vivantes.de

    Peter Kohl, MD

    Recruiting

  • Dept. of Dermatology, Medical Center Buxtehude

    Buxtehude, Lower Saxony, D-21641

    Peter Mohr, MD, +49-4161-7036297, mohrpe@cs.com

    Peter Mohr, MD

    Recruiting

  • Dept. of Dermatology, Helios Clinic Erfurt

    Erfurt, Thuringia, 99012

    Ruthild Linse, MD, +49-361-7814300

    Ruthild Linse, MD

    Recruiting

  • Dept. of Dermatology, University of Frankfurt

    Frankfurt am Main, Hesse, D-60590

    Konstanze Spieth, MD, +49-69-6301-5311, konstanze.spieth@kgu.de

    Konstanze Spieth, MD

    Recruiting

  • Dept. of Dermatology, Hildesheim

    Hildesheim, Lower Saxony, D-31134

    Michael Tronnier, MD, +49-05121-894821

    Michael Tronnier, MD

    Recruiting

  • Dept. of. Dermatology, University of Saarland, Homburg

    Homburg, Saaland, D-66421

    Wolfgang Tilgen, MD, +49-6841-3800, hawtil@med-rz-sb.de

    Dorothea Tadler, MD

    Recruiting

  • Dept. of Dermatology, University of Jena

    Jena, Thuringia, D-07740

    Martin Kaatz, MD, +49-3641-937302, kaatz@derma.uni-jena.de

    Martin Kaatz, MD

    Recruiting

  • Dept. of Dermatology, University of Schleswig-Holstein

    Kiel, Schleswig-Holstein, D-24105

    Axel Hauschild, MD, +49-431-596-1613, ahauschild@dermatology.uni.kiel.de

    Axel Hauschild, MD

    Recruiting

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

    Lübeck, Schleswig-Holstein, D-23538

    Sven Krengel, MD, +49-451-5002517, svenkrengel@gm.net

    Sven Krengel, MD

    Recruiting

  • Dept. of Dermatology, University Otto von Guericke

    Magdeburg, Saxony-Anhalt, D-39120

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

    Vassiliki Bekou, MD, +49-391-6715264, vassiliki.bekou@medizin.uni-magdeburg.de

    Recruiting

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

    Mannheim, Baden-Wurttemberg, D-68167

    Dirk Schadendorf, MD, +49-621-3832127, d.schadendorf@dkfz.de

    Dirk Schadendorf, MD

    Recruiting

  • Dept. of Dermatology, University Hospital Tuebingen

    Tübingen, Baden-Wurttemberg, D-72076

    Claus Garbe, MD, +49-7071-2980872, studienzentrum-derm-onko@med.uni-tuebingen.de

    Claus Garbe, MD

    Recruiting

Other trials in Germany

About this study

Official title: Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

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%.

Being tested
Cisplatin, Vindesine, Dacarbazine (drugs)
Keywords
malignant Melanoma, Chemotherapy, Metastasis, standard palliative care, best supportive care
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cisplatin, Vindesine, Dacarbazine (drugs)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (4)

  1. Quality of life analysis

  2. Objective tumor response rate in study arm B

  3. Time to tumor progression

  4. Cost analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2005 (estimated)
  2. Study startSep 2001
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226473
Sponsor's protocol ID
ADO-MM-PAL8
Status last verified
Sep 2005
First submitted
25 Sep 2005
Last updated
21 Jun 2006
Results posted
No

Publications

  • 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.

    PubMed 10561349

  • 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.

    PubMed 10561229

  • 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.

    PubMed 10661773

  • 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.

    PubMed 9093725

  • 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.

    PubMed 11308250

  • 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.

    PubMed 10839290

  • 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.

    PubMed 10403690

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cisplatin, Vindesine, Dacarbazine (drugs) in people with Metastatic Melanoma, run by Dermatologic Cooperative Oncology Group at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jens Ulrich, MD (+49-391-6715428, jens.ulrich@medizin.uni-magdeburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00226473, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in