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

NCIC Clinical Trials Group7 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

干预措施

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: 7
主要终点: Response duration (median and range)

研究概览研究设计入排标准研究组 & 干预措施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

•DISEASE CHARACTERISTICS:
•Histologically confirmed cutaneous malignant melanoma
•Recurrent or metastatic disease that is not curable by surgical or other means
•Clinically and/or radiologically documented disease defined as at least one site of disease unidimensionally measurable ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan
•Must have nonbulky metastatic disease defined as the largest measurable lesion ≤ 50 mm in maximum diameter
•Must have primary diagnosis tumor tissue or previously resected metastatic melanoma tissue available (i.e., paraffin block or unstained slides)
•No known brain metastases
•PATIENT CHARACTERISTICS:
•ECOG performance status 0-2
•Life expectancy ≥ 12 weeks
•Absolute granulocytes count ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•Bilirubin normal
•Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
•AST and ALT ≤ 2.5 times ULN
•Negative pregnancy test
•Not pregnant or nursing
•Fertile patients must use effective contraception during study therapy
•No uncontrolled intercurrent illness or condition including, but not limited to, any of the following:
•Ongoing or active infection
•Symptomatic congestive heart failure
•Unstable angina pectoris
•Cardiac arrhythmia
•Psychiatric illness or social situation that would limit compliance with study requirements
•No history of hemolysis or a hemolytic disorder including, but not limited to, any of the following:
•Sickle cell anemia
•Thalassemia
•Autoimmune hemolytic anemia
•No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease
•No known HIV, hepatitis B, or hepatitis C infection
•Patients must reside within a 2-hour drive from a participating center
•PRIOR CONCURRENT THERAPY:
•No previous systemic therapy for metastatic disease
•At least 3 months since prior adjuvant immunotherapy for recurrent melanoma
•No prior immunotherapy for metastatic disease
•No prior immunotherapy outside the adjuvant setting
•At least 4 weeks since prior major surgery
•At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy and recovered
•More than 4 weeks since prior and no concurrent investigational agents or anticancer therapy
•No prior chemotherapy including regional therapy
•No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone)
•Concurrent topical steroids are allowed

排除标准

未提供

研究组 & 干预措施

Recombinant human interleukin-21

Experimental

干预措施: pharmacological study (Other)

Recombinant human interleukin-21

Experimental

干预措施: recombinant human interleukin-21 (Biological)

Recombinant human interleukin-21

Experimental

干预措施: immunohistochemistry staining method (Other)

Recombinant human interleukin-21

Experimental

干预措施: laboratory biomarker analysis (Other)