EUCTR2011-000572-33-DE进行中（未招募）不适用
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
Oryx GmbH und Co. KG0 个研究点目标入组 18 人开始时间: 2011年3月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age over/equal 18 year,
- •2.Diagnosis of glioblastoma multiforme,
- •3.Written informed consent,
- •4.Recurrent or progressive disease despite previous radio- and/or chemotherapy,
- •5.Indication for complete or subtotal tumor resection,
- •6.Life expectancy of at least 3 months,
- •7.Consent for sampling and investigation of biological specimens,
- •8.Karnofsky Performance Score over/equal 60,
- •9.Adequate seizure control,
- •10.Adequate bone marrow function: neutrophils >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL,
- •11.Adequate liver function: Bilirubin <2.0 g/dL, ASAT, ALAT, AP, GGT <3 x ULN,
- •12.Adequate renal function: Creatinine <1.8 g/dL,
- •13.Adequate blood clotting: aPTT <35 sec, INR <1.2,
- •14.Negative serology for HIV, HBV and HCV,
- •15.Negative Beta-HCG test in women of childbearing potential,
- •16.Commitment to use adequate contraception (in both genders) for up to six months after study entry,
- •17.Commitment to omit exposure to infants <18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
- •18. Only for Group III: feasibilitly of intratumoral injection of 2.5 mL IMP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1.Multifocal disease,
- •2.Evidence of distant tumor metastases,
- •3.Contraindications for MRI,
- •4.Active infection within 5 days prior to the study inclusion,
- •5.Chemotherapy within 4 weeks prior to the study inclusion,
- •6.Radiotherapy within 6 weeks prior to the study inclusion,
- •7.Participation in another interventional trial within the last 30 days,
- •8.Treatment with antiangiogenic substances within 21 days prior to therapy
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