Conditions: Melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Concurrent decrescendo biochemotherapy regimen intervention 2: Low-dose Temozolomide plus Sorafenib
Intervention descriptions: intervention 1: * Temozolomide: 200mg/m\^2, daily, PO, days 1-4
* Vinblastine: 1.5mg/m\^2, daily, IV, days 1-4
* Cisplatin: 20mg/m\^2, daily IV, days 1-4
* IL (interleukin)-2: - 18 milli-International unit (MIU)/m\^2, IVCI (intravenous continual infusion), day 1
* 9 MIU/m\^2, IVCI, day 2
* 4.5 MIU/m\^2, IVCI, days 3 \& 4
* Interferon (IFN) alpha: 5 MIU/m\^2, daily, SC (subcutaneously), days 1-5
* 5-day inpatient regimen, to be repeated every 21 days intervention 2: Temozolomide: 75mg/m\^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

Protocol document: