NCT01301430已完成1 期
Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
详细描述
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
H-1PV will primarily be administered either intratumoral or intravenously. Ten days thereafter a complete or a subtotal tumor resection with a subsequent administration of H-1PV into the walls of the resection cavity will be carried out.
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
- •Age over or equal to 18 years old,
- •Diagnosis of glioblastoma multiforme,
- •Written informed consent,
- •Recurrent or progressive disease despite previous radio- and/or chemotherapy,
- •Indication for complete or subtotal tumor resection,
- •Life expectancy of at least 3 months,
- •Consent for sampling and investigation of biological specimens,
- •Karnofsky Performance Score over or equal to 60,
- •Adequate seizure control,
- •Adequate bone marrow function: neutrophils > 1.5 x 10exp9/L, platelets > 100 x 10exp9/L, hemoglobin > 9.0 g/dL,
- •Adequate liver function: Bilirubin < 2.0 g/dL, ASAT, ALAT, AP, GGT < 3 x ULN,
- •Adequate renal function: Creatinine < 1.8 g/dL,
- •Adequate blood clotting: aPTT < 35 sec, INR < 1.2,
- •Negative serology for HIV, HBV and HCV,
- •Negative Beta-HCG test in women of childbearing potential,
- •Commitment to use adequate contraception (in both genders) for up to six months after study entry,
- •Commitment to omit exposure to infants < 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
排除标准
- •Multifocal disease,
- •Evidence of distant tumor metastases,
- •Contraindications for MRI,
- •Active infection within 5 days prior to the study inclusion,
- •Chemotherapy within 4 weeks prior to the study inclusion,
- •Radiotherapy within 6 weeks prior to the study inclusion,
- •Participation in another interventional trial within the last 30 days,
- •Treatment with antiangiogenic substances within 21 days prior to therapy.
研究组 & 干预措施
H-1 parvovirus (H-1PV)
Experimental
干预措施: H-1PV (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Up to 28 days after the first administration of the IMP
Parameters for assessment of safety and tolerability: * physical/neurological examinations (pathological findings as quality and quantity) * adverse events (quality and quantity per dose level) * vital signs, ECG, laboratory parameters (pathological findings as quality and quantity, for laboratory parameters: descriptive statistics) * viral shedding and viral specific antibodies (quantity depicted over time)
次要结局
- Efficacy (treatment response)(Up to 6 months after the first administration of the IMP)
研究者
研究点 (1)
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