NCT00003993已完成1 期
A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
National Institute on Aging (NIA)2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 1999年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.
- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.
- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.
- Assess any anti-tumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of interleukin-2.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists
- •Prostate cancer patients must have the following:
- •Tumor progression following blockade of both testicular and adrenal androgens
- •Serum testosterone in the castrate range (less than 20 ng/mL)
- •At least 3 months since prior suramin therapy
- •At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment
- •Luprolide should continue if no prior orchiectomy
- •No prior or concurrent brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,500/mm^3 OR
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 8 g/dL
- •Hepatitis B surface antigen negative
- •PT no greater than 14 seconds
- •PTT no greater than 35 seconds
- •Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease
- •SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Albumin at least 2.5 g/dL
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL
- •Cardiovascular:
- •No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment
- •No evidence of CAD on EKG
- •FEV1-1 at least 70% predicted
- •DLCO at least 60% predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •At least 1 week since active infection requiring antibiotics
- •No other medical or psychiatric condition that would preclude study
- •No prior or concurrent seizure disorders controlled with medication
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior interleukin-2
- •At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior bryostatin 1
- •At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas
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排除标准
- 未提供
研究者
研究点 (2)
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