A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 13
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin.
- Determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks.
Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study
- •Tumor and/or any associated edema limited to one hemisphere and unifocal
- •No gross invasion of a ventricular surface
- •Tumor accessible
- •No other astrocytoma
- •No multifocal or recurrent malignant glioma
- •No disease below the tentorium or beyond the cranial vault
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •At least 8 weeks
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal
- •Blood Urea Nitrogen (BUN) no greater than 25 mg/dL
- •Creatinine no greater than 1.5 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No hypersensitive or idiosyncratic reaction to bleomycin
- •No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder
- •No other major medical illness or psychiatric impairment that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for glioblastoma multiforme
- •No prior radiosensitizer for glioblastoma multiforme
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields
- •See Disease Characteristics
- •Recovered from prior surgery
排除标准
- 未提供
研究组 & 干预措施
Radiation therapy followed by bleomycin via Ommaya reservoir
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
干预措施: Ommaya reservoir (Device)
Radiation therapy followed by bleomycin via Ommaya reservoir
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
干预措施: radiation therapy (Radiation)
Radiation therapy followed by bleomycin via Ommaya reservoir
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
干预措施: bleomycin (Biological)
结局指标
主要结局
Overall Survival
时间窗: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
次要结局
未报告次要终点