NCT00006968已完成1 期
Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
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. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral stem cell transplantation in treating patients who have advanced kidney cancer.
详细描述
OBJECTIVES:
- Determine the duration and efficiency of hematopoietic and immunologic engraftment in patients with advanced renal cell carcinoma treated with pentostatin followed by related allogeneic stem cell transplantation.
- Determine the hematologic and non-hematologic toxic effects of this regimen in these patients.
- Determine the incidence and severity of graft-versus-host disease in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of pentostatin.
- Phase I: Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously until stem cell engraftment and then orally with gradual tapering.
Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose 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 confirmed advanced renal cell cancer
- •No bone metastases
- •No CNS disease
- •Must have an allogeneic donor available
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •3 to 6 months
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •Complete blood count normal
- •Bilirubin no greater than 3 times upper limit of normal (ULN)
- •Transaminases no greater than 4 times ULN
- •No evidence of portal hypertension
- •Creatinine no greater than 2.0 mg/dL
- •No uncontrolled hypercalcemia
- •Cardiovascular:
- •No New York Heart Association class 3 or 4 heart disease
- •DLCO at least 40% of predicted
- •No severe functional neurological impairment
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than 1 prior biologic therapy
- •Chemotherapy:
- •No more than 6 months of prior chemotherapy
- •Endocrine therapy:
- •At least 1 year since prior steroids
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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