A randomized double blind controlled proof of concept study of the efficacy and safety of Valcyte® as an add-on therapy in patients with malignant glioblastoma with successful surgical resection of at least 90 % of the initial tumor and CMV infection demonstrated histollogically and immunohistochemically. - VIGAS

Phase 1

• Conditions: Malignant Glioblastoma with CMV infection demonstrated histologically and immunohistochemically; MedDRA version: 8.1Level: LLTClassification code 10018336Term: Glioblastoma

• Registration Number: EUCTR2006-002022-29-SE
• Lead Sponsor: Karolinska Institutet, Center for Molecular medicine, L8:03 L8:03

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-22
• Study Completion: 2008-06-06
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients aged 18 years or above
Patients diagnosed with malignant glioblastoma, with successful surgical resection of at least 90 % of the initial tumor
Patients diagnosed with CMV infection in the tumour by detection of CMV-proteins using immunohistochemistry.
Patients providing written informed consent.
Patients cooperative and able to complete all the assessment procedures.
Patient agrees to utilize two reliable methods of contraception combined throughout the study period and for 90 days following discontinuation of the Study Drug.
Females of childbearing potential must have a negative pregnancy test at screening.

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

Patients allergic to, or who do not tolerate Valcyte® treatment
Patients who do not want to take Valcyte® treatment
Pregnant or lactating females
Women of child bearing age not willing to use reliable form of contraception
Patient requires the use of any prohibited concomitant medications
Currently receiving other experimental therapy
Patient is simultaneously participating in another clinical trial
Absolute neutrophil count < 1500 cells/mm3
Platelet count < 150 000 cells/ mm3
HGB < 8g/dL
Abnormal renal function
Current other severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study

Study & Design

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