NCT01152788

Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

A Randomized Phase II Study of Interleukin-21 (rIL-21) Versus Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	rIL-21	30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
DRUG	Dacarbazine	1000 mg/m2 IV Day 1, every 3 weeks

Timeline

• Start date: 2010-08-05
• Primary completion: 2014-11-25
• Completion: 2015-02-13
• First posted: 2010-06-29
• Last updated: 2023-08-22
• Results posted: 2014-07-21

Locations

19 sites across 2 countries: United States, Canada