Operable high grade primary or recurrent glioma MedDRA version: 7.0 Level: PT Classification code 10018338
Conditions
Interventions
Product Name: Cerepro
Product Code: EG009
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: EG009
Other descriptive name: Adv.HSV-tk virus
Concentration unit: DF dosage
Sponsors
Ark Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are suspected of having high-grade operable glioma 2. Male or female patients who are between 18 and 70 years of age (male and female patients of childbearing potential must agree to use an acceptable method of contraception for the period that they are receiving GCV. Male patients must continue to use an acceptable method of contraception for 90 days thereafter) 3. Karnofsky score > 70 4. Patients who signed the informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who are suspected of having infratentorial high-grade operable glioma 2. Patients with a medical or psychiatric condition that compromises their ability to participate in the study. 3. Patients who have received an investigational drug within 30 days or five half-lives of study enrollment. 4. Patients with known or suspected drug or alcohol abuse in the past 6 months. 5. Patients who are known to be human immunodeficiency virus (HIV)-positive 6. Patients with other significant disease, including renal or liver disease (creatinine>350 ?mol/l, alanine aminotransferase [ALT]>200 U/l) 7. Patients who are allergic to GCV or for whom GCV is contra-indicated 8. Patients with bihemispheric or multifocal tumours 9. Patients who receive chemotherapy within six weeks prior to randomisation 10. Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare all cause mortality in patients receiving CereproTM with subsequent GCV for the treatment of operable primary or recurrent high-grade glioma when used as an adjuvant to standard therapy ;Secondary Objective: • To compare progression-free survival in patients with operable primary or recurrent glioma treated with CereproTM/GCV compared to those receiving standard therapy alone • To assess the safety of CereproTM/GCV therapy in patients with operable primary or recurrent glioma. • To assess the Quality of Life of patients receiving CereproTM/GCV therapy compared with those receiving standard therapy alone ;Primary end point(s): Primary efficacy endpoint: • All cause mortality | — |
Countries
Czech Republic, Finland, Hungary
Outcome results
None listed