Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma
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.
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. ;
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