A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan With Venous Filtration for Metastatic Unresectable Cancers of the Liver
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer.
详细描述
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial infusion with melphalan in patients with unresectable liver cancer.
- Determine the regional and systemic toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo percutaneous hepatic arterial infusion, using a double balloon catheter in the inferior vena cava to isolate circulation to the liver, with melphalan over 30 minutes on day 1. Treatment may be repeated when all toxic effects are grade 2 or less. Patients undergo staging at 4 weeks after completion of the second treatment. Patients may receive 2 additional treatments.
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated with melphalan at the recommended dose.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed unresectable cancer of the parenchyma of the liver
- •Liver metastases allowed
- •Limited unresectable extrahepatic disease (including but not limited to the following) is allowed provided the life-threatening component of progressive disease is in liver:
- •Up to 4 pulmonary nodules each less than 1 cm in diameter
- •Retroperitoneal lymph nodes less than 3 cm in diameter
- •Fewer than 10 skin or subcutaneous metastases less than 1 cm in diameter
- •Asymptomatic bone metastases that have been or can be palliated with radiotherapy
- •Solitary metastasis to any site that can be resected
- •Prior therapy with intrahepatic perfusion with or without hepatic arterial infusion with floxuridine is allowed provided patient had a radiographic partial response of 3-months duration
- •PATIENT CHARACTERISTICS:
- •14 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3
- •Absolute neutrophil count at least 1,300/mm^3
- •Hematocrit greater than 27%
- •Bilirubin no greater than 2.0 mg/dL
- •PT within 2 seconds of upper limit of normal
- •No biopsy-proven cirrhosis with evidence of portal hypertension by history, endoscopy, or radiologic study
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No prior congestive heart failure with LVEF less than 40%
- •No chronic obstructive pulmonary disease
- •No other chronic pulmonary disease
- •FEV_1 at least 30% of predicted
- •DLCO at least 40% of predicted
- •Weight greater than 35 kg
- •HIV negative
- •No active infections
- •No severe allergic reaction to iodine contrast not controlled by antihistamines or steroids
- •No known prior hypersensitivity reaction to melphalan
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 month since prior biologic therapy for the malignancy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •At least 1 month since prior chemotherapy for the malignancy and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 1 month since prior radiotherapy for the malignancy and recovered
- •Not specified
- •No concurrent chronic anticoagulants
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排除标准
- 未提供