E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant Glioblastoma with CMV infection demonstrated histologically and immunohistochemically |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018336 |
E.1.2 | Term | Glioblastoma |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To evaluate that the study drug passes to the brain by microdialysis in patients reop |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
All patients will be followed for 28 weeks after evaluation of surgical treatment and possible inclusion into the study, this includes 24 weeks of treatment with Valcyte/placeba and a 4 week followup. In all 40 patinets are planned which will take between 6 to 12 months to recrute into the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |