CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
rIL-21 +1 moredrug
Likely dose
rIL-21 30 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01152788
NCT01152788Phase 2Completed
CompareCT.gov

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

NCIC Clinical Trials Group·interventional·Posted Jun 29, 2010·Updated Aug 22, 2023

In Brief

A Phase 2 clinical trial evaluating rIL-21 and Dacarbazine for Melanoma. Completed, enrolled 64 participants across 19 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2010
Enrollment StartAug 5, 2010
Primary CompletionNov 25, 2014
Study CompletionFeb 13, 2015
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.0 years ago

Interventions

rIL-21drug

30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks

Dacarbazinedrug

1000 mg/m2 IV Day 1, every 3 weeks