Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 20
研究概览
简要总结
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13-receptor positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells.
详细描述
PHASE I OBJECTIVES:
I. To describe toxicities and estimate the maximum safe flow rate and maximum tolerated infusion concentration, of IL13-PE38QQR delivered after surgical resection by peritumoral infusion via 2 to 4 catheters positioned in the brain adjacent to the resection cavity, from the start of infusion through the DLT observation period.
II. To determine the IL13 receptor alpha-2 chain expression status and distribution in pediatric recurrent or progressive malignant gliomas.
III. To describe the overall safety and tolerability of IL13PE38QQR infusion from the start of infusion through disease progression or initiation of alternative treatment.
PHASE II OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Characteristics-
- •Must be at least 3 years but not more than 21 years of age.
- •Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma, mixed anaplastic astrocytoma, or glioblastoma multiforme.
- •Must have radiographic evidence of recurrent or progressive supratentorial malignant glioma compared with a prior imaging study. The baseline tumor measurements must be determined within 2 weeks prior to study entry.
- •The tumor must have a solid component at least 1.0 cm in diameter.
- •Gross total resection must be planned, with the intent of removing all contrast-enhancing components of the tumor.
- •Must have received external beam radiotherapy, with tumor dose of at least 48 Gy; and must be completed at least 8 weeks prior to study entry.
- •Patient Characteristics-
- •Karnofsky Performance Score for patients older than 16 years, or the Lansky Performance Scale for patients 16 years old or younger, must be at least
- •Hematologic status: Absolute neutrophils at least 1,500/mm3; Hemoglobin at least 10 gm/dL (transfusion independent); Platelets at least 100,000/mm3 (transfusion independent); PT & aPTT less than or equal to the institutional upper limit of normal.
- •Must have recovered from toxicity of prior therapy: at least 6 months after Gliadel® wafer; at least 8 weeks after hematopoietic stem cell transplant; at least 4 weeks after any cytotoxic chemotherapy or any systemic investigational agent; at least 6 weeks after nitrosoureas; at least 2 weeks after vincristine or non-cytotoxic chemotherapy.
- •Patient's legal guardian must understand the investigational nature of this study and its potential risks and benefits; must sign informed consent.
- •No pregnant or breast-feeding patients. All patients of child-bearing age, male and female, must practice an effective method of birth control during the study.
- •No patients with multi-focal tumor not amenable to gross total resection or tumor dissemination (subependymal or leptomeningeal).
- •No patients with clinically significant increased intracranial pressure (e.g., impending herniation) uncontrolled seizures, or requirement for immediate palliative treatment.
- •No patients who received any localized antitumor therapy for the malignant glioma, either intracerebral chemotherapy (other than Gliadel®) or focal radiation therapy (e.g., stereotactic radiosurgery or brachytherapy).
- •No patients who are receiving concurrent chemotherapy (other than steroids) or any other investigational agent.
- •No patients unwilling to follow protocol requirements.
排除标准
- 未提供