Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 22
研究概览
简要总结
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma.
PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.
详细描述
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma.
- Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen.
- Determine the toxic effects of this drug at the MTD in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin 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. Additional patients are treated at the MTD.
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 proven malignant glioma (grade 3 or 4)
- •Anaplastic astrocytoma
- •Glioblastoma multiforme
- •Malignant mixed oligoastrocytoma
- •Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study
- •Must have undergone supratentorial brain tumor surgery or biopsy
- •Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study
- •Must have solid portion measuring 1.0-5.0 cm in maximum diameter
- •Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm
- •No tumor crossing the midline
- •No leptomeningeal tumor dissemination
- •No impending herniation or spinal cord compression
- •No uncontrolled seizures
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Hemoglobin at least 10 g/dL
- •Platelet count at least 100,000/mm^3
- •PT and PTT no greater than upper limit of normal (ULN)
- •SGOT and SGPT no greater than 2.5 times ULN
- •Bilirubin no greater than 2.0 mg/dL
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior intralesional chemotherapy for malignant glioma
- •At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study
- •Radiotherapy:
- •See Disease Characteristics
- •No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma
- •See Disease Characteristics
- •Recovered from any prior therapy
- •No other concurrent investigational agent
排除标准
- 未提供