H-1 Parvovirus for treatment of malignant brain tumors (glioblastoma multiforme)

Active, not recruiting

• Conditions: Glioblastoma multiforme; MedDRA version: 15.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000572-33-DE
• Lead Sponsor: Oryx GmbH und Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Age over/equal 18 year,
2.Diagnosis of glioblastoma multiforme,
3.Written informed consent,
4.Recurrent or progressive disease despite previous radio- and/or chemotherapy,
5.Indication for complete or subtotal tumor resection,
6.Life expectancy of at least 3 months,
7.Consent for sampling and investigation of biological specimens,
8.Karnofsky Performance Score over/equal 60,
9.Adequate seizure control,
10.Adequate bone marrow function: neutrophils >1.5 x 109/L, platelets >100 x 109/L, hemoglobin >9.0 g/dL,
11.Adequate liver function: Bilirubin <2.0 g/dL, ASAT, ALAT, AP, GGT <3 x ULN,
12.Adequate renal function: Creatinine <1.8 g/dL,
13.Adequate blood clotting: aPTT <35 sec, INR <1.2,
14.Negative serology for HIV, HBV and HCV,
15.Negative Beta-HCG test in women of childbearing potential,
16.Commitment to use adequate contraception (in both genders) for up to six months after study entry,
17.Commitment to omit exposure to infants <18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.
18. Only for Group III: feasibilitly of intratumoral injection of 2.5 mL IMP
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1.Multifocal disease,
2.Evidence of distant tumor metastases,
3.Contraindications for MRI,
4.Active infection within 5 days prior to the study inclusion,
5.Chemotherapy within 4 weeks prior to the study inclusion,
6.Radiotherapy within 6 weeks prior to the study inclusion,
7.Participation in another interventional trial within the last 30 days,
8.Treatment with antiangiogenic substances within 21 days prior to therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified