A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma
- 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.
- To investigate whether rIL-21 induced sCD25 release is independent of the level of
- To investigate the effect of rIL-21 on antibody induction during treatment and
- 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response as assessed by RECIST
after completion of treatment
Teresa M. Petrella
Edmond Odette Cancer Centre at Sunnybrook
Canada: Health Canada