Clinical trial · Interventional
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
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.
NCT01301430CI-TRIAL-00062278ParvOryx01completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| H-1PV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- H-1 parvovirus (H-1PV)
- interventionNames
- Drug: H-1PV
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- Up to 28 days after the first administration of the IMP
- description
- 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 outcomes (1)
- measure
- Efficacy (treatment response)
- timeFrame
- Up to 6 months after the first administration of the IMP
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDGeletneky K, Huesing J, Rommelaere J, Schlehofer JR, Leuchs B, Dahm M, Krebs O, von Knebel Doeberitz M, Huber B, Hajda J. 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: ParvOryx01 protocol. BMC Cancer. 2012 Mar 21;12:99. doi: 10.1186/1471-2407-12-99. PMID 22436661
- BACKGROUNDGeletneky K, Leoni AL, Pohlmeyer-Esch G, Loebhard S, Baetz A, Leuchs B, Roscher M, Hoefer C, Jochims K, Dahm M, Huber B, Rommelaere J, Krebs O, Hajda J. Pathology, organ distribution, and immune response after single and repeated intravenous injection of rats with clinical-grade parvovirus H1. Comp Med. 2015 Feb;65(1):23-35. PMID 25730754
- BACKGROUNDGeletneky K, Leoni AL, Pohlmeyer-Esch G, Loebhard S, Leuchs B, Hoefer C, Jochims K, Dahm M, Huber B, Rommelaere J, Krebs O, Hajda J. Bioavailability, biodistribution, and CNS toxicity of clinical-grade parvovirus H1 after intravenous and intracerebral injection in rats. Comp Med. 2015 Feb;65(1):36-45. PMID 25730755
- BACKGROUNDGeletneky K, Hajda J, Angelova AL, Leuchs B, Capper D, Bartsch AJ, Neumann JO, Schoning T, Husing J, Beelte B, Kiprianova I, Roscher M, Bhat R, von Deimling A, Bruck W, Just A, Frehtman V, Lobhard S, Terletskaia-Ladwig E, Fry J, Jochims K, Daniel V, Krebs O, Dahm M, Huber B, Unterberg A, Rommelaere J. Oncolytic H-1 Parvovirus Shows Safety and Signs of Immunogenic Activity in a First Phase I/IIa Glioblastoma Trial. Mol Ther. 2017 Dec 6;25(12):2620-2634. doi: 10.1016/j.ymthe.2017.08.016. Epub 2017 Aug 24. PMID 28967558