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

NCIC Clinical Trials Group14 个研究点分布在 1 个国家目标入组 40 人开始时间: 2007年12月13日最近更新: 2023年8月4日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: NCIC Clinical Trials Group
入组人数: 40
试验地点: 14
主要终点: Objective tumor response as assessed by RECIST

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标