Phase I Testing of ADI-PEG in Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
研究概览
简要总结
This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.
详细描述
The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.
In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic melanoma
- •Nonresectable disease
- •Measurable or evaluable disease
- •Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy
- •Recovered from prior surgery
- •Karnofsky performance status 70 or higher
- •Expected survival of at least 12 weeks
- •Bilirubin less than 2.0 mg/dL
- •Albumin greater than 3.0 g/dL
- •SGOT less than 5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 5 times ULN
- •Ammonia less than 55 microg/dL
- •Glucose greater than 60 mg/dL
- •Amylase less than 1.5 times ULN
- •Absolute neutrophil count greater than 1,500/mm3
- •Platelet count greater than 100,000/mm3
- •Patients must use 2 forms of effective contraception
排除标准
- •Prior therapy within the past 4 weeks
- •Ascites or pleural effusion
- •Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)
- •Pregnant or nursing
- •Concurrent enrollment in another IND study
- •Serious infection requiring antibiotics