Patients diagnosed of Glioblastoma
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TEMOZOLOMIDA
Current Sponsor code: PR1
Other descriptive name: TEMOZOLOMIDE
Conc
Sponsors
GEINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand and sign the informed consent document . 2 . Age greater than or equal 18. 3 . Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease. 4. Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made ??in the center of origin the result of the center will be accepted ) . 5 . Stable dose of dexamethasone in the inclusion never above corticides dose received in cycle 6 of the adjuvant . 6. Index greater than or equal 60 % Karnofsky 7. All patients must show no progression of disease in a brain MRI as defined in RANO established criteria before randomization . 8. Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle. ( MRI performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed) 9. Adequate bone marrow reserve : hematocrit ? 29% , WBC> 3,000 / mcL , RAN ? 1,500 cells / ul , platelets ? 100,000 cells / ul. 10. Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: 1. Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted. 2. Concomitant treatment with other investigational agents (other concomitant bevacizumab) . 3. Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth. 4. Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol. 5. Concurrent disease that prevents the continuation of treatment temozolomia . 6. Any treatment or surgery after initial diagnosis irradiation since starting treatment with radiotherapy and adjuvant temozolomide and .. 7. Intratumoral BCNU therapy in surgery for tumor recurrence ( second surgery ) . NOTE : Patients treated with intratumoral BCNU (or what is the same carmustine intratumoral or Gliadel ® ) in the first intervention can participate in the study. 8. Presence of leptomeningeal dissemination. 9. Pregnant or breastfeeding. 10. Positive patients receiving combination antiretroviral therapy in HIV
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Profile / toxicity Tumoral activity Global survival Changes in the use of corticosteroids Changes in neurological status MGMT methylation ;Timepoint(s) of evaluation of this end point: Patient exitus | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Detect differences in the probability of progression-free survival at 6 months between patients with methylated or unmethylated MGMT and residual disease or not, to receive an additional 6 cycles of temozolomide.; Secondary Objective: Perfil de Seguridad/toxicidad Actividad Tumoral Supervivencia Global Cambios en el uso de corticoides Cambios en el estado neurológico Metilación de MGMT ;Primary end point(s): The primary efficacy endpoint is progression-free survival at 6 months or overall progression-free survival, according to the methylation status of the MGMT gene or the presence of residual disease at baseline MRI in patients with glioblastoma who have already received 6 cycles of adjuvant without progress and are randomized to continue with 6 cycles of TMZ or stop treatment.;Timepoint(s) of evaluation of this end point: Progression-free survival at 6 months after end of treatment | — |
Countries
Spain
Contacts
Public ContactMFAR S.L.
Marketing Farmacéutico Investigación Clínica
Outcome results
None listed