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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome 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)

Outcome Time Frame:

Up to 28 days after the first administration of the IMP

Safety Issue:

Yes

Principal Investigator

Andreas Unterberg, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Neurosurgery, University Hospital Heidelberg

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

ParvOryx01

NCT ID:

NCT01301430

Start Date:

September 2011

Completion Date:

May 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Progressive glioblastoma multiforme
  • Recurrent glioblastoma multiforme
  • Oncolytic virus
  • Glioblastoma
  • Parvoviridae Infections

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