A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High Grade Malignant Glioma - ASPECT

• Conditions: Operable high grade primary or recurrent glioma; MedDRA version: 7.0Level: PTClassification code 10018338

• Registration Number: EUCTR2004-000464-28-HU
• Lead Sponsor: Ark Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

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