Conditions: Melanoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.

Detailed description:

Arms:
arm 1: 6 ug/kg/week, SC (first 8 weeks)

3 ug/kg/week, SC (252 weeks \[weeks 9-260\], maintenance)

Interventions: intervention 1: PEG-Intron
Intervention descriptions: intervention 1: None

Protocol document: