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

NCT01152788 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-22

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Teresa Petrella · Odette Cancer Centre - Sunnybrook Health Sciences Centre, Toronto, ON

  • Kerry Savage · BCCA - Vancouver Cancer Centre, Vancouver, BC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01152788 on ClinicalTrials.gov