EUCTR2011-000572-33-DE
Active, not recruiting
Not Applicable
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 sites18 target enrollmentMarch 16, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Oryx GmbH und Co. KG
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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,
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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