drugset / Trial / NCT01152788

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

NCT01152788

Phase 2 Completed 64 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08-05
Primary completion
2014-11-25
Completion
2015-02-13

Publications

  • Results Petrella TM, Mihalcioiu C, Monzon J, McWhirter E, Belanger K, Savage KJ, Song X, Hamid O, Cheng T, Davis M, Lee CW, Spatz A, Hagerman L, Chen BE, Dancey J Final Efficacy Results of a Randomized Phase II Study of Recombinant Interleukin-21 Compared to Dacarbazine in Patients with Recurrent or Metastatic Melanoma Journal of Oncology Research and Treatment:4(1):10001322019

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dacarbazine Small molecule 1000 mg/m2 Intravenous
Comparator Recombinant Human Interleukin-21 Protein / enzyme biologic 30 ug/kg Intravenous

Indications