Trial | NCT00226473  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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%.
Study Started
Sep 30
2001
Study Completion
Sep 30
2005
Last Update
Jun 21
2006
Estimate

Drug Cisplatin, Vindesine, Dacarbazine (drugs)

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)
No Results Posted