Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
Condition: Glioblastoma
MeSH terms: Glioblastoma
Intervention: Temozolomide
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles
      improve progression-free survival in patients with glioblastoma included in this study,
      randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and
      residual disease or not, to receive an additional 6 cycles of temozolomide.
    

Eligibility 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 corticoids 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 nuclear magnetic resonance
             (NMR) 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 ( NMR performed after the 6th
             cycle of adjuvant is also acceptable as long as no progression was observed).

          9. Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell>
             3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000
             cells / ul.

         10. Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the
             analysis.

         11. Serum bilirubin <1.5 / ULN; SGOT , SGPT < 2.5 times the upper limit of normal of the
             laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases .

         12. Effective contraceptive method in patients and their partners.

        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 temozolomide treatment.

          6. Presence of leptomeningeal dissemination.

          7. Pregnant or breastfeeding.

          8. Positive patients receiving combination antiretroviral therapy in HIV