Conditions: Melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment.

This research is being done because currently there is no effective treatment for this type of cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: rIL-21 intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks intervention 2: 1000 mg/m2 IV Day 1, every 3 weeks

Protocol document: