Multiforme Glioblastom (MGB) is the more common malignant brain tumor, with an incidence around 4 cases per 100.000 hab/year. MedDRA version: 19.0 Level: LLT Classification code 10029110 Term: Neoplasms of unspecified nature System Organ Class: 100000004864
Conditions
Sponsors
Clínica Universidad de Navarra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients willing and able to give informed consent. 2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures. 3. Age over 18 4. Negative pregnant test in case of fertile women* 5. Patients with suspected diagnosis of Glioblastoma based on MRI, 5. The tumor should be considered candidate to resection surgery by the investigator criteria or being less than 4cm in bigger diameter if the tumor is considered unresectable or the patient is unwilling to have resection surgery. 6. A diagnosis of High Grade Glioma should be confirmed during surgical procedure. 7. Karnofsky Performance Status = 60 before inclusion Or could use "candidate to resection surgery" in number 5 to select cases with good enough situation and eliminate this criterium, preoperative situation in newly diagnosed can be tricky as sometimes a deficit at presentation of the disease can improve. 8. Must have adequate renal, bone marrow and liver function. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., 4 times over upper normal laboratory level. 9. Neutrophils < 1.5 x 109/L 10. Thrombocytes = 100 x 109/L 11. Hemoglobin < 9g/dl 12. If final pathology diagnose of a patient would fail to confirm the suspected diagnosis of glioblastoma or any of its variants (like gliosarcoma, giant-cell glioblastoma, or any other), that patient would follow the procedures of the trial and would be counted for toxicity analysis, but not for survival analysis. 13. Patients with Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways. 14. Biologic/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks of DNX-2401 administration. 15. Vaccination of any kind within 30 days prior to DNX-2401 administration. 16. Inability to undergo MRI examination for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Survival.;Secondary Objective: 1. To evaluate changes in quality of life (QoL) based on results of the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-BN20, and EORTC-QLQ-C30. 2. Volumetric change in tumor 2.1 Volumetric change of the contrast-enhancing tumor volume 2. 2 Volumetric changes of FLAIR abnormal volume 3. Progression Free survival based on iRANO;Primary end point(s): Overall Survival. The mean comparative groups for survival would be Group A versus B1 and B1 versus B2, so the number would be similar. Survival will be also compared to survival expected from a published calculator of GBM survival which takes into account age, KPS, EOR and intention to treat with radiotherapy plus temozolomide (Marko et al J Clin. Onc. 2014). This calculator provides the OS expected for each patient considering his prognostic factors (Age, KPS, EOR), so for each case it will be calculated if he has lived longer or shorter than expected.;Timepoint(s) of evaluation of this end point: Overall Survival between groups will be compared through Kaplan-Meier curve, so comparison will use the full follow-up. a comparison will also be made with OS at two year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To evaluate changes in quality of life (QoL) based on results of the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-BN20, and EORTC-QLQ-C30. 2. Volumetric change in tumor 2.1 Volumetric change of the contrast-enhancing tumor volume 2. 2 Volumetric changes of FLAIR abnormal volume 3. Progression Free survival based on iRANO;Timepoint(s) of evaluation of this end point: - QOL will be determined in clinical visits at 12, 18 and 24 months, using (EORTC QLQ-BN20 and EORTC-QLQ-C30) - Tumor volume changes: Tumor volumes will be manually drawn in each slice in software Brainlab iplannet, however different software could be used later if, at the criteria of the PI, provides similar results. After the measurements done, The following volumes will be quantified at all the scheduled MRIs on the calendar visit, preoperartively, later afrter surgery at 1-3 days, 4, 14, 22 weeks, 9, 12, 15, 18, 21, 24 and 30 months: These volumes will be collected and analized as an spider plot. - Progression free survival. PFS will be determined by iRANO criteria and compared through Kaplan Meier curve in all the follow-up. | — |
Countries
Spain
Contacts
Public ContactUCEC
Clínica Universidad de Navarra
Outcome results
None listed