Malignant Glioblastoma with CMV infection demonstrated histologically and immunohistochemically MedDRA version: 8.1 Level: LLT Classification code 10018336 Term: Glioblastoma
Conditions
Interventions
Trade Name: Valcyte
Product Name: Valcyte
Product Code: 107-9070
Pharmaceutical Form: Tablet
INN or Proposed INN: Valganciclovir
CAS Number: 175865-60-8
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Karolinska Institutet, Center for Molecular medicine, L8:03 L8:03
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The evaluation of the efficacy and safety of Valcyte as add-on therapy to Standard of care in patient with malignant glioblastoma with successful surgical resection of at least 90 % of the initial tumor and CMV infection demonstrated histollogically and immunohistochemically. ;Secondary Objective: Determine and compare between the 2 arms: - Patient survival and mean survival time - Proportion of progressive disease - Proportion of stable disease - Proportion of patients with treatment failure - Surgical interventions needed to control disease - Proportion of adverse events, laboratory abnormalities and serious adverse events - Evaluation of different aspects of cytomegalovirus infection and of immune response to CMV infection and correlation with patient outcome. ;Primary end point(s): Primary endpoints are a comparison between the 2 arms of the tumor size assessed by MRI at week 12 and week 24 in comparison with the post-operative MRI after the initiation of the study drug Definition of response Target lesions measurement will be assessed by the 2 largest perpendicular diameters on the MRI at week 12 and 24 in comparison with the MRI performed after surgery. Treatment response is defined as stable or a growth less than 25 % of the size of the target lesion | — |
Countries
Sweden
Outcome results
None listed