1. Male or Female, aged >18 years.
2. Karnofsky Performance Scale (KPS)> 60
3. Imaging confirmation of first tumor progression o regrowth as defined by Response
Assessment in Neuro-Oncology Criteria (RANO) criteria at least 12 weeks after
completion of radiotherapy, unless the recurrence is outside the radiation field or
has been histologically documented
4. Recurrence after adjuvant treatment( surgery followed by radiotherapy and
chemotherapy) in patients who could receive further therapeutic interventions
5. No more than one prior line of chemotherapy (one line of chemotherapy after concurrent
and adjuvant Temozolomide (TMZ)
- - based chemotherapy or
procarbazine/lomustine/vincristine (PCV) - Radiotherapy (RT)
Patients who have undergone recent surgery for recurrent o progressive high grade
gliomas are eligible provided that : surgery must have confirmed the recurrence ; a
minimum of 28 days must have elapsed from the days of surgery to study . For core or
needle biopsy a minimum of 7 days must have elapsed prior to study .
7. If female and of child bearing potential , have a negative result on a pregnancy test
performed a maximum of 7 days before initiation .
8. Female participants of child bearing potential and male participants whose partner is
of child bearing potential must be willing to ensure that they or their partner use
effective contraception during the study and for 4 months thereafter
9. Have adequate bone marrow function , liver function , and renal function , as measured
by following laboratory assessments conducted within 7 days prior to the initiation of
study treatment .
10. Hemoglobin >9.0 g/dl
11. Absolute neutrophil count (ANC) >1500/mm3 without transfusions or granulocyte colony
stimulating factor and other hematopoietic growth factors
12. Platelet count ≥90,000/μl
13. White Blood Cell (WBC) >3.0 x 109/L
14. Total bilirubin <1.5 times the upper limit of normal
15. Serum creatinine <1.5 x upper limit of normal
16. Participant is willing and able to give informed consent for participation in the
1. Radiotherapy within 12 weeks prior to the diagnosis of progression, if the lesion is
in the radiation field.
2. Patients with cardiopulmonary diseases (heart failure, bolus emphysema, pneumothorax,
chronic obstructive pulmonary disease (COPD) with hypercapnia sinusitis )
3. Closed angle-glaucoma with pressure ocular superior to 24 mmHg