Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 13
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.
Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.
The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.
详细描述
During the radiation treatment period subjects will receive:
- Focal radiation delivered as 60 Gray/30 fractions scheduled at 2 Gray/day for 5 days each week (Monday through Friday) for 6 weeks.
- Temozolomide 75mg/m2 orally once daily (usually administered the night preceding each radiation session) starting the evening before the first radiation session over a period of 42 calendar days with a maximum of 49 days.
- TSC 0.25 mg/kg IV for 3 days each week (Monday, Wednesday, Friday) administered between 45 to 60 minutes prior to each radiation session.
Pneumocystis carinii pneumonia (PCP) prophylaxis is required during Temozolomide + radiation administration, regardless of lymphocyte count and is to continue until recovery of lymphocyte count to less than or equal to Grade 1.
During the 28-day rest period all subjects will receive no treatment.
During the post-radiation 6-cycle temozolomide treatment period subjects will receive:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects who are at least 18 to 70 years of age
- •Have histologically confirmed GBM
- •The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
- •Measurable (>10mm x 10mm) contrast enhancing disease.
- •Limited disturbance of tumor during biopsy.
- •Surgical and pathology reports that document surgery was limited to biopsy and histologic confirmation.
- •Life expectancy of at least 3 months.
- •Subjects must have a Karnofsky score (KPS) of ≥ 60 at Screening.
- •Glucocorticoid therapy allowed.
- •Tumor Treatment Field (TT Fields) therapy allowed.
- •If female, the subject must have a negative serum or urine pregnancy test at Screening unless meeting non-productive potential criteria.
- •Subjects must have hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dL, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
- •The subject or subject's medical power of attorney has provided written consent to participate in this study.
排除标准
- •Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
- •Subjects must not have had prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy.
- •Subject who is pregnant or lactating.
- •Subject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety.
- •Subject who cannot undergo MRI.
- •Subject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.
- •Subjects with other uncontrolled medical conditions, e.g. myocardial infarction, cerebrovascular accident, diabetes or hypertension.
- •Subjects diagnosed with another malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix.
- •CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting).
研究组 & 干预措施
Trans Sodium Crocetinate plus SOC
Trans Sodium Crocetinate plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
干预措施: Trans Sodium Crocetinate plus SOC (Drug)
Standard of Care (SOC)
Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Overall Survival (OS)
时间窗: All subjects will be followed for 24 months
Overall survival will be calculated from randomization to the time of death from any cause
次要结局
未报告次要终点