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

Phase 1

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: H-1PV

• Registration Number: NCT01301430
• Lead Sponsor: Oryx GmbH & Co. KG

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Study Start: 2011-09
• Status Verified: 2015-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
H-1 parvovirus (H-1PV)	H-1PV	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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)

Secondary Outcome Measures

Name	Time	Method
Efficacy (treatment response)	Up to 6 months after the first administration of the IMP	Parameters for evaluation of efficacy: * Progression free survival (PFS) based on modified RECIST-criteria depicted as Kaplan-Meier curve; * Overall survival (OS) depicted as Kaplan-Meier curve

Trial Locations

Locations (1)

Department of Neurosurgery, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany