A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 19
- 主要终点
- Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
研究概览
简要总结
This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.
详细描述
This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.
The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.
High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.
Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient must have a histologically confirmed unilateral, supratentorial malignant glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or malignant oligoastrocytoma)
- •Patient must have glioma progression or recurrence following radiotherapy that was no less than 50 Gy (+/- chemotherapy; +/- surgery)
- •Patient must be a candidate for resection of the recurrent tumor (surgical requirements are detailed in the study protocol)
- •Imaging must show recurrent, unilateral, supratentorial tumor(s)
- •There is no diffuse leptomeningeal disease
- •For patients with previous radiosurgery or enhanced radiotherapy, based on neurosurgeon's judgment, the area of enhancement can be removed during the surgery
- •Patient must have recovered from toxicity of prior therapy
- •Patient must be > 18 years of age.
- •Patient has a Karnofsky Performance Status greater than or equal to 60%
- •Patient must have a life expectancy of at least 3 months
- •Patient has no uncontrolled seizures or other neurological conditions which would interfere with evaluation
- •Patient is not currently receiving, or is not anticipated to receive, concomitant anticancer agent(s) during the course of this study
- •Patient must have given informed consent
排除标准
- •Patient with concurrent malignancy (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with prior malignancies that have not been disease-free for five years
- •Patient has presence of non-contiguous satellite lesions
- •Patient with known allergy to iodine, iodine containing drugs or contrast agent
- •Patient with the potential for pregnancy or impregnating their partner and who do not agree to follow an acceptable birth control method to avoid conception
- •Pregnant or breast feeding females
- •Patient is not maintained on a stable corticosteroid regimen
- •New onset of conditions not present prior to surgery (as detailed in Study Protocol) which would make patient an inappropriate study candidate, or as determined by Investigator
研究组 & 干预措施
1
3 Dose Regimen
干预措施: 131-I-TM-601 (Drug)
2
6 Dose Regimen
干预措施: 131I-TM601 (Drug)
结局指标
主要结局
Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
时间窗: 28 days post last dose
Determine the toxicity of a three (3) and six (6) dose cycle of 131-I-TM-601 administrations into the tumor resection site of patients with recurrent high-grade glioma
时间窗: 28 days post last dose and then at 3 month intervals from first dose, until disease progression
Evaluate the 6 and 12-month rate of progression and survival of patients with recurrent high-grade glioma treated with a three (3) or six (6) dose cycle of 131-I-TM-601
时间窗: at 3 month intervals from first dose administration, until disease progression
Evaluate the overall time to progression and death of patients with recurrent high-grade glioma treated with either a three (3) or six (6) dose cycle of 131-I-TM-601
时间窗: at 3 month intervals until disease progression
次要结局
- Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life(3 month intervals until disease progression)