Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Patients with Dose Limiting Toxicity (DLT)
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.
详细描述
OBJECTIVES:
- Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas.
- Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.
OUTLINE: This is a two arm, randomized study. The first arm includes all histologically benign meningiomas. The second arm includes all other pathologies.
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks. Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable.
Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven tumors:
- •Unresectable meningioma
- •Atypical meningioma
- •Malignant meningioma
- •Angioblastic meningioma
- •Hemangiopericytoma
- •Recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Karnofsky at least 60%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •AGC at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •SGPT less than 2.0 times normal
- •Alkaline phosphatase less than 2.0 times normal
- •Bilirubin less than 1.5 mg/dL
- •BUN less than 1.5 times normal OR
- •Creatinine less than 1.5 times normal
- •No active infection
- •No diseases that obscure toxicity or dangerously alter drug metabolism
- •No serious intercurrent medical illness
- •Not pregnant
- •Fertile patients must use adequate contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy
- •Chemotherapy:
- •Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy
- •Endocrine therapy:
- •Prior hormonal therapy allowed
- •No concurrent hormonal therapy
- •Radiotherapy:
- •Prior radiotherapy allowed
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Benign Meningiomas
INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.
干预措施: Recombinant Interferon Alfa (INF alpha) (Biological)
Arm 2: Other Pathologies
INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
干预措施: Recombinant Interferon Alfa (INF alpha) (Biological)
结局指标
主要结局
Number of Patients with Dose Limiting Toxicity (DLT)
时间窗: Each 8 weeks
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
次要结局
未报告次要终点