NCT00514085

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

A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * To assess the efficacy, in terms of objective response rate, nonprogression rate, time to progression, and response duration, in patients with metastatic or recurrent malignant melanoma treated with recombinant human interleukin-21 (rIL-21). * To assess the toxicity and safety of rIL-21 in patients with previously untreated metastatic or recurrent malignant melanoma. * To characterize the pharmacokinetics of rIL-21. * To characterize the effects of rIL-21 on lymphocyte cell count and soluble CD25 (sCD25) in serum as potential biomarkers for drug activity. * To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. * To assess melanoma antigenic markers for response and nonprogression on archival tissue from patients enrolled on the study. Secondary * To investigate whether rIL-21 induced sCD25 release is independent of the level of circulating sCD25. * To investigate the effect of rIL-21 on antibody induction during treatment and preexisting immunogenicity. * To assess lymphocyte cell-count changes over time in relation to rIL-21 therapy. OUTLINE: This is a multicenter study. Patients receive recombinant human interleukin-21 (rIL-21) IV on days 1-5 of weeks 1, 3 and 5. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) or partial response (PR) receive 2 courses beyond CR or PR. Patients with stable disease receive a maximum of 3 courses of rIL-21. Previously archived tumor tissue and blood samples are collected from patients for correlative studies. Samples are analyzed for soluble CD25, rIL-21 antibodies, circulating lymphocyte counts, preexisting immonogenicity to rIL-21 for antibody induction, and expression of common melanoma tumor antigen markers via IHC. After completion of study treatment, patients are followed at 4 weeks.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-13
• Primary completion: 2010-09-02
• Completion: 2012-07-04
• First posted: 2007-08-09
• Last updated: 2023-08-04

Locations

7 sites across 1 country: Canada