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

• Status: Unknown status
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermatologic Cooperative Oncology Group
• Treatments: Dacarbazine; Vindesine

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)