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

Primary Purpose

Metastatic Melanoma

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cisplatin, Vindesine, Dacarbazine (drugs)
Sponsored by
Dermatologic Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring malignant Melanoma, Chemotherapy, Metastasis, standard palliative care, best supportive care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of MannheimRecruiting
  • Dept. of Dermatology, University Hospital TuebingenRecruiting
  • Dept. of Dermatology, University of FrankfurtRecruiting
  • Dept. of Dermatology, Medical Center BuxtehudeRecruiting
  • Dept. of Dermatology, HildesheimRecruiting
  • Dept. of. Dermatology, University of Saarland, HomburgRecruiting
  • Dept. of Dermatology, University Otto von GuerickeRecruiting
  • Dept. of Dermatology, University of Schleswig-HolsteinRecruiting
  • Dept. of Dermatology, University of Schleswig-Holstein, Campus LübeckRecruiting
  • Dept. of Dermatology, Helios Clinic ErfurtRecruiting
  • Dept. of Dermatology, University of JenaRecruiting
  • Dept. of Dermatology, Charité BerlinRecruiting
  • Dept. of Dermatology, Vivantes ClinicsRecruiting

Outcomes

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

Full Information

First Posted
September 25, 2005
Last Updated
June 20, 2006
Sponsor
Dermatologic Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00226473
Brief Title
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Official Title
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dermatologic Cooperative Oncology Group

4. Oversight

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
malignant Melanoma, Chemotherapy, Metastasis, standard palliative care, best supportive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cisplatin, Vindesine, Dacarbazine (drugs)
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Quality of life analysis
Title
Objective tumor response rate in study arm B
Title
Time to tumor progression
Title
Cost analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Ulrich, MD
Phone
+49-391-6715428
Email
jens.ulrich@medizin.uni-magdeburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Ulrich, MD
Organizational Affiliation
Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Axel Hauschild, MD
Organizational Affiliation
Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Mohr, MD
Organizational Affiliation
Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
D-68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Schadendorf, MD
Phone
+49-621-3832127
Email
d.schadendorf@dkfz.de
First Name & Middle Initial & Last Name & Degree
Dirk Schadendorf, MD
Facility Name
Dept. of Dermatology, University Hospital Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
D-72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Garbe, MD
Phone
+49-7071-2980872
Email
studienzentrum-derm-onko@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Claus Garbe, MD
Facility Name
Dept. of Dermatology, University of Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
D-60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstanze Spieth, MD
Phone
+49-69-6301-5311
Email
konstanze.spieth@kgu.de
First Name & Middle Initial & Last Name & Degree
Konstanze Spieth, MD
Facility Name
Dept. of Dermatology, Medical Center Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
D-21641
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Mohr, MD
Phone
+49-4161-7036297
Email
mohrpe@cs.com
First Name & Middle Initial & Last Name & Degree
Peter Mohr, MD
Facility Name
Dept. of Dermatology, Hildesheim
City
Hildesheim
State/Province
Niedersachsen
ZIP/Postal Code
D-31134
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tronnier, MD
Phone
+49-05121-894821
First Name & Middle Initial & Last Name & Degree
Michael Tronnier, MD
Facility Name
Dept. of. Dermatology, University of Saarland, Homburg
City
Homburg
State/Province
Saaland
ZIP/Postal Code
D-66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Tilgen, MD
Phone
+49-6841-3800
Email
hawtil@med-rz-sb.de
First Name & Middle Initial & Last Name & Degree
Dorothea Tadler, MD
Facility Name
Dept. of Dermatology, University Otto von Guericke
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
D-39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Ulrich, MD
Phone
+49-391-6715428
Email
jens.ulrich@medizin.uni-magdeburg.de
First Name & Middle Initial & Last Name & Degree
Vassiliki Bekou, MD
Phone
+49-391-6715264
Email
vassiliki.bekou@medizin.uni-magdeburg.de
First Name & Middle Initial & Last Name & Degree
Vassiliki Bekou, MD
Facility Name
Dept. of Dermatology, University of Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
D-24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Hauschild, MD
Phone
+49-431-596-1613
Email
ahauschild@dermatology.uni.kiel.de
First Name & Middle Initial & Last Name & Degree
Axel Hauschild, MD
Facility Name
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
D-23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Krengel, MD
Phone
+49-451-5002517
Email
svenkrengel@gm.net
First Name & Middle Initial & Last Name & Degree
Sven Krengel, MD
Facility Name
Dept. of Dermatology, Helios Clinic Erfurt
City
Erfurt
State/Province
Thuringia
ZIP/Postal Code
99012
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruthild Linse, MD
Phone
+49-361-7814300
First Name & Middle Initial & Last Name & Degree
Ruthild Linse, MD
First Name & Middle Initial & Last Name & Degree
Yvonne Kellner, MD
Facility Name
Dept. of Dermatology, University of Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
D-07740
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kaatz, MD
Phone
+49-3641-937302
Email
kaatz@derma.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Martin Kaatz, MD
Facility Name
Dept. of Dermatology, Charité Berlin
City
Berlin
ZIP/Postal Code
D-10098
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwe Trefzer, MD
Phone
+49-30-450518063
Email
uwe.trefzer@charite.de
First Name & Middle Initial & Last Name & Degree
Maja Hofmann, MD
Phone
+49-30-450518063
Email
maja.hofmann@charite.de
First Name & Middle Initial & Last Name & Degree
Uwe Trefzer, MD
Facility Name
Dept. of Dermatology, Vivantes Clinics
City
Berlin
ZIP/Postal Code
D-12351
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Kohl, MD
Phone
+49-30-60043601
Email
p.kohl@vivantes.de
First Name & Middle Initial & Last Name & Degree
Peter Kohl, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10561349
Citation
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.
Results Reference
background
PubMed Identifier
10561229
Citation
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.
Results Reference
background
PubMed Identifier
10661773
Citation
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.
Results Reference
background
PubMed Identifier
9093725
Citation
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.
Results Reference
background
PubMed Identifier
11308250
Citation
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.
Results Reference
background
PubMed Identifier
10839290
Citation
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.
Results Reference
background
PubMed Identifier
10403690
Citation
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.
Results Reference
background

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

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