Metastatic Melanoma
Conditions
Keywords
malignant Melanoma, Chemotherapy, Metastasis, standard palliative care, best supportive care
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%.
Interventions
DRUGCisplatin, Vindesine, Dacarbazine (drugs)
Sponsors
Dermatologic Cooperative Oncology Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life analysis | — |
| Objective tumor response rate in study arm B | — |
| Time to tumor progression | — |
| Cost analysis | — |
Countries
Germany
Contacts
Primary ContactJens Ulrich, MD
Outcome results
None listed