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

Dermatologic Cooperative Oncology Group

Status and phase: Unknown; Phase 4

Conditions: Metastatic Melanoma

Treatments: Drug: Cisplatin, Vindesine, Dacarbazine (drugs)

Study type: Interventional

Funder types: Other

Identifiers

NCT00226473

ADO-MM-PAL8

Details and patient eligibility

About

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%.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)