home/imdoinit.org

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01301430
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oryx GmbH & Co. KG
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andreas Unterberg, Prof. Dr.Bernard Huber, Dr.
Principal Investigator Affiliation	Department of Neurosurgery, University Hospital HeidelbergOryx GmbH & Co. KG
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Additional Details

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.

Arms & Interventions

Arms

Experimental: H-1 parvovirus (H-1PV)

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Heidelberg, Germany

Status

Address

Department of Neurosurgery, University Hospital Heidelberg

Heidelberg, , 69120

Clinical Trial Finder