Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme. (ParvOryx01)
This study is currently recruiting participants.
Verified September 2011 by Oryx GmbH & Co. KG
Sponsor:
Oryx GmbH & Co. KG
Information provided by (Responsible Party):
Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01301430
First received: February 21, 2011
Last updated: September 27, 2011
Last verified: September 2011
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Purpose
Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme |
Drug: H-1PV |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Further study details as provided by Oryx GmbH & Co. KG:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: Up to 28 days after the first administration of the IMP ] [ Designated as safety issue: Yes ]
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:
- Efficacy (treatment response) [ Time Frame: Up to 6 months after the first administration of the IMP ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 19 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: H-1 parvovirus (H-1PV) |
Drug: H-1PV
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).
Other Name: ParvOryx (brand name of H-1PV)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301430
Contacts
| Contact: Karsten Geletneky, Dr. | +49 06221/5639 ext 672 | Karsten.Geletneky@med.uni-heidelberg.de |
| Contact: Jacek Hajda, Dr. | +49 06221/5634 ext 507 | Jacek.Hajda@med.uni-heidelberg.de |
Locations
| Germany | |
| Department of Neurosurgery, University Hospital Heidelberg | Recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Karsten Geletneky, Dr. +49 06221/56 39 ext 672 karsten.Geletneky@med.uni-heidelberg.de | |
| Principal Investigator: Karsten Geletneky, Dr. | |
Sponsors and Collaborators
Oryx GmbH & Co. KG
Investigators
| Principal Investigator: | Andreas Unterberg, Prof. Dr. | Department of Neurosurgery, University Hospital Heidelberg |
| Study Director: | Bernard Huber, Dr. | Oryx GmbH & Co. KG |
More Information
No publications provided by Oryx GmbH & Co. KG
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oryx GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT01301430 History of Changes |
| Other Study ID Numbers: | ParvOryx01 |
| Study First Received: | February 21, 2011 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Oryx GmbH & Co. KG:
|
Progressive glioblastoma multiforme Recurrent glioblastoma multiforme Oncolytic virus |
Additional relevant MeSH terms:
|
Glioblastoma Parvoviridae Infections Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013