A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
Complexity Level: 2
Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.
Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.
NCT Registration ID (from clinicaltrials.gov): NCT01152788
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2010 Closing Date: February 29, 2012
Chair: (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2641, (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662