Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oryx GmbH & Co. KG

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.