PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME MedDRA version: 9.1 Level: LLT Classification code 10018337 MedDRA version: 9.1 Level: LLT Classification code 10018337
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 40-
Pharmaceutical Form: Film-
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Age > = 18 years - Histologically confirmed grade IV glioma that was progressive or recurrent after first line treatment of concomitant chemo-radiotherapy - Measurable disease according to RECIST Criteria - ECOG PS =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluded medical conditions: 1. Hystory of cardiac disease:congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension. 2. History of HIV infection or chronic hepatitis B or C (This criteria should be modified to allow Hepatitis B or C in protocols looking at HCC patient population). 3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 4. History of organ allograft The organ allograft may be allowed as protocol specific. 5. Patients with evidence or history of bleeding diasthesis 6. Patients undergoing renal dialisis 7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. Excluded therapies and medications, previous and concomitant: 1. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. 2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study 3. Autologous bone marrow transplant or stem cell rescue within 4 months of study 4. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study] 5. Investigational drug therapy outside of this trial during or within 4 weeks of study entry 6. Prior exposure to the study drug. To be used only in case of single agent trials. 7. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 3 months after the completion of trial. 8. Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results 9. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 10. Patients unable to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 6-months Progression Free Survival;Secondary Objective: Quality of life /Changes in steroids assumption Response rate according to RECIST criteria Progression Free Survival & Overall Survival Toxicity profile Evaluation of VEGF, sVEGFR-2 and TSP-1 plasma levels Evaluation of the inhibition ERK phosphorylation in PBMC of treated patients;Primary end point(s): progressionfree survival | — |
Countries
Italy
Outcome results
None listed