Clinical Trial in patients with glioblastoma

Phase 1

• Conditions: Patients diagnosed of Glioblastoma; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000838-39-ES
• Lead Sponsor: GEINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

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 <1.5 times the upper limit of normal 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.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified