Status: Closed
Activation Date: 2010JUN28
Closing Date: 2012FEB29
Phase: II
Description: A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
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.
Objective: 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.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to compare the effectiveness of rIL-21 given by intravenous injection daily x 5 in weeks 1, 3 and 5 every 8 weeks and dacarbazine given by intravenous injection Day 1 every 3 weeks in patients with metastatic or recurrent incurable malignant melanoma. We will also be looking at side-effects and safety of these two drugs. The main purpose of this study is to find out whether 50ug/kg/day of rIL-21 is safe to give to patients, but most importantly, to study its effectiveness and side-effects when given on 5 consecutive days weeks 1, 3 and 5. Researchers will also look at blood levels to find out how the drug is distrubuted in the blood and to study the effects on the system. Additional research will investigate tissue samples from previously removed melanoma lesions.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I202 | 64 | 32 | 55 | 60 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I202 | 64 | 1 | 22 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I202 | 64 | 42 | 0 | 0 | 0 | 59 | 60 | 0 | 0 |