PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
研究概览
简要总结
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study.
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
- •Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection
- •Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery
- •Tumor must be at least 1.0 cm from the optic chiasm and brainstem
- •No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas
- •No infratentorial tumors
- •No multifocal glioblastoma multiforme
- •Tumor enhances on MRI
- •Must have visible tumor on postoperative MRI following surgical resection
- •Performance status - Karnofsky 60-100%
- •At least 3 months
- •Hemoglobin at least 10.0 g/dL
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGPT no greater than 60 U/L
- •Creatinine no greater than 1.3 mg/dL
- •Blood urea nitrogen no greater than 24 mg/dL
- •Neurological function status 0-3
- •No evidence of neuropathy
- •No glucose-6-phosphate dehydrogenase deficiency
- •No known history of porphyria
- •History of prior malignancies allowed
- •HIV positive status allowed
- •No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception prior to and during study
- •At least 6 weeks since prior chemotherapy
- •Concurrent steroids allowed
- •No prior radiotherapy to the brain or upper neck
- •No greater than 5 weeks since prior surgery and recovered
排除标准
- 未提供
研究组 & 干预措施
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: conventional surgery (Procedure)
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: stereotactic radiosurgery (Radiation)
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: motexafin gadolinium (Drug)
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: magnetic resonance imaging (Procedure)
Treatment (motexafin gadolinium, radiotherapy, radiosurgery)
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.
干预措施: spectroscopy (Procedure)
结局指标
主要结局
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
时间窗: At the time of stereotactic radiosurgery
次要结局
- Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry(At baseline, at 48 hours, and at 2 weeks post-surgery)