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

Oryx GmbH & Co. KG18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

H-1PVDRUG

H-1PV administered at three increasing doses either intratumorally or intravenously and then 10 days after the first administration intracerebrally (into the walls of tumor resection cavity).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Safety and tolerability

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)

Time frame: Up to 28 days after the first administration of the IMP

Secondary Outcomes

Efficacy (treatment response)

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

Time frame: Up to 6 months after the first administration of the IMP

Data from ClinicalTrials.gov

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