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Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

NCT00514085 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-04

No results posted yet for this study

Summary

RATIONALE: Interleukin-21 may stimulate white blood cells, including natural killer cells, to kill melanoma cells.

PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works in treating patients with metastatic or recurrent malignant melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

recombinant human interleukin-21

Patients enrolled in Part A will receive treatment daily x 5 on weeks 1, 3, and 5 of an 8 week cycle. Patients enrolled in Part B will receive treatment daily x 5 on weeks 1, and 3 of a 6 week cycle

OTHER

immunohistochemistry staining method

Cycle 1 Day 1 and Cycle 1 Day 29

OTHER

laboratory biomarker analysis

slides will be blocked for 15 minutes in 20% normal goat serum and then incubated in primary antibody

OTHER

pharmacological study

Starting dose of 50μg/kg/day as an IV push

Sponsors & Collaborators

  • ZymoGenetics

    collaborator INDUSTRY

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Teresa M. Petrella · Toronto Sunnybrook Regional Cancer Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-13
Primary Completion
2010-09-02
Completion
2012-07-04

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00514085 on ClinicalTrials.gov