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Clinical Trials/EUCTR2011-000572-33-DE
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.

Registry
who.int
Start Date
March 16, 2011
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Oryx GmbH und Co. KG

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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