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 primary glioblastoma
MedDRA version: 7.0Level: PTClassification code 10018338

Registration Number: EUCTR2004-000464-28-CZ

Lead Sponsor: Ark Therapeutics Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1.Patients who have a supratentorial primary gliomablastoma multiformae [GBM]. The diagnosis is based on radiological and clinical grounds.
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 with recurrent gliomas.
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
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

Primary Outcome Measures

Name	Time	Method
Main Objective: •To determine if CereproTM/GCV is superior to standard care for the treatment of operable primary glioblastoma based on time to death or re-intervention (re-intervention is defined as ny kind of treatment [including surgery, radiotherapy or chemotherapy] given to prolong survival when a tumour recurs). ;Secondary Objective: •To determine if CereproTM/GCV is superior to standard care for the treatment of operable primary glioblastoma based on all cause mortality.<br>•Tumour progression by MRI.<br>•To assess the safety of CereproTM/GCV therapy in patients with operable primary glioblastoma.<br>•To assess the Quality of Life of patients receiving CereproTM/GCV therapy compared with those receiving standard therapy alone. <br>;Primary end point(s): Primary efficacy endpoint: <br>•Time to death or re-intervention<br>

Secondary Outcome Measures

Name	Time	Method

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