NCT00062049已完成1 期
A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors.
详细描述
OBJECTIVES:
- Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors.
- Determine a range of biologically active doses of this drug in these patients.
- Determine the biological effects of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive interleukin-7 (IL-7) subcutaneously on days 0, 2, 4, 6, 8, 10, 12, and 14 (for a total of 8 doses) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) and "biologically active dose" (BAD) are determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The BAD is defined as the dose that produces a sustained 50% increase in CD3+ count over the patient's baseline without unacceptable 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 confirmed malignancy meeting both of the following criteria:
- •No known curative therapy
- •Failed standard therapy, defined as either lack of response OR disease progression (i.e., at least 25% increase in disease or new disease)
- •Measurable or evaluable disease
- •No hematopoietic malignancies
- •No primary carcinoma of the lung
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •No proliferative hematologic disease
- •AST and ALT less than 3 times upper limit of normal (ULN)
- •PT/PTT no greater than 1.5 times ULN
- •No documented hepatitis B infection
- •No documented hepatitis C infection
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular
- •Ejection fraction greater than 45% by MUGA
- •Hypertension (resting blood pressure greater than 140/90 mm Hg) must be controlled with standard anti-hypertensive therapy
- •No severe asthma
- •DLCO/VA greater than 50% of predicted
- •FEV_1 greater than 50% of predicted
- •Immunologic
- •No autoimmune disease
- •Peripheral CD3+ cell count greater than 300/mm^3 and stable on 4 successive determinations
- •HIV negative
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other medical or psychiatric condition that would preclude study compliance
- •No cognitive impairment or likelihood of developing cognitive impairment during study participation
- •No need for palliative therapy
- •No splenomegaly
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy by cytokines, anti-tumor vaccines, or monoclonal antibody therapy prior to the initiation of peripheral CD3 count determination
- •No prior allogeneic hematopoietic stem cell transplantation
- •No other concurrent immunotherapy
- •No other concurrent biologic agents (e.g., growth factors or monoclonal antibodies)
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •No prior systemic corticosteroid therapy for more than 72 hours within the 2 weeks prior to initiation of peripheral CD3 cell count determination
- •No concurrent chronic steroid therapy
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (3)
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