Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.
详细描述
OBJECTIVES:
- Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma.
- Assess other intermediate markers of immune response in patients treated with this regimen.
- Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma
- •Unresectable disease
- •No known uncontrolled CNS metastases
- •CNS metastases allowed only if recently irradiated or known to be controlled
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 8 g/dL
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Absolute lymphocyte count at least 1,000/mm^3
- •Total bilirubin no greater than 1.5 mg/dL OR
- •Conjugated bilirubin no greater than 0.3 mg/dL
- •AST no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No uncontrolled hypertension, angina, or congestive heart failure
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study
- •No known intolerance to acetaminophen
- •No primary or secondary immunodeficiency
- •No other condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •At least 1 month since prior topical, systemic, or inhaled corticosteroids
- •No concurrent topical, systemic, or inhaled corticosteroids
- •Radiotherapy:
- •See Disease Characteristics
- •Not specified
排除标准
- 未提供