NCT00857025已完成1 期
A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer
City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年11月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Biological therapies, such as beta-glucan, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan in treating patients with locally advanced or metastatic non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To assess the feasibility and toxicity of therapy with beta-glucan MM-10-001 in patients with locally advanced or metastatic non-small cell lung cancer for which standard curative or palliative measures do not exist or are no longer effective.
Secondary
- To explore analysis of the effect of beta-glucan MM-10-001 on the innate immune compartment, in particular natural killer cell activation and effector status.
- To perform correlatives (cytokine profiling) that will explore the effects of beta-glucan MM-10-001 on the cytokine profile of these patients.
- To document all clinical responses of these patients after treatment with beta-glucan MM-10-001.
- To explore potential beta-glucan MM-10-001 dose effects on the patient-reported functional status.
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:
- •Pathologically confirmed non-small cell lung cancer
- •Locally advanced or metastatic disease for which standard curative or palliative measures do not exist or are no longer effective
- •Unresectable disease
- •No active or symptomatic brain metastases unless they were previously treated by radiotherapy or surgery, stabilized, AND off steroid therapy for ≥ 4 weeks
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- •Life expectancy > 3 months
- •WBC > 2,000/mm³
- •Absolute neutrophil count > 1,000/mm³
- •Platelet count > 50,000/mm³
- •Total bilirubin < 1.5 times upper limit of normal (ULN)
- •AST and ALT < 2.5 times ULN
- •Serum creatinine < 2.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must be able to swallow enteral medications (patients with feeding tubes are eligible)
- •No condition or disease that affects gastrointestinal (GI) function or impairs the ability to take oral medications including any of the following:
- •GI tract disease
- •No intractable nausea or vomiting
- •Malabsorption syndrome
- •Requirement for IV alimentation
- •Prior surgical procedures effecting absorption
- •Uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)
- •No concurrent condition requiring the use of systemic or topical steroids or the use of immunosuppressive agents
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to beta-glucan MM-10-001
- •No uncontrolled concurrent illness 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
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
- •Concurrent palliative radiotherapy for symptoms control allowed
- •At least 2 weeks since prior corticosteroids and no concurrent systemic or topical steroids
- •At least 7 days since prior antioxidant supplements (vitamin C and E)
- •No other concurrent investigational agents
- •Bisphosphonate therapy (e.g., pamidronate or zoledronate) allowed
- •No concurrent over-the-counter or dietary supplement containing beta-glucan (e.g., mushroom extracts, "lentinan" products, dried mushrooms) or other mushroom-derived powders, liquids, capsules, gels, or any other dosage form
- •No concurrent use of immunosuppressive agents (e.g., cyclosporine and its analog)
- •No concurrent darbepoetin alfa or epoetin alfa
- •No concurrent colony-stimulating factors
- •No concurrent antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 28 days after therapy begins
Toxicity as assessed by NCI CTCAE v3.0
时间窗: 28 days after therapy begins
Maximum-tolerated dose
时间窗: 28 days after therapy begins
次要结局
- Survival(1 year after start of study)
- Beta-glucan MM-10-001 activity as assessed by changes in natural killer cell activation and functional activity, cytokine profiling, and clinical benefit(13 weeks after start of study treatment)
- Patient-reported functional status(13 weeks after start of study treatment)
- Progression-free survival(1 year after start of study)
研究者
研究点 (2)
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