Study of Sunitinib Before and During Radiotherapy in Newly Diagnosed Biopsy-only Glioblastoma Patients

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Sunitinib seems to be a promising treatment for the objective of this proposal: to evaluate the clinical activity of Sunitinib as first line therapy in patients who have measurable disease and to evaluate the safety of Sunitinib with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Investigación en Neurooncología
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

1. Patients with glioblastoma, non resectable, who have only a biopsy as surgical treatment.

2. Measurable disease and with contrast capture of 2cm

3. Stable doses of DXM during the week before the inclusion

4. Performance status 0-1-2

5. Age < 75 years

6. MMS > 25/30

7. Barthel index > 50%

8. Surgical incision must have healed before the inclusion

9. Basal MRI done 3 weeks at the most before the beginning of the treatment which has specified conditions at the protocol.

10. FEVI > 50%

11. Suitable medullar reserve (neutrophils _2000x109/L, platelets _ 100x109/L, Haemoglobin _ 10 g/dl.)

12. Not previous chemotherapy or radiation treatment.

13. Creatinin < 1,5 times the superior standard limit of the laboratory in charged of the analysis.

14. Serum Bilirubin < 1, 5/ULN, SGOT y SGPT _ 2,5 times the superior standard limit of the laboratory in charged of the analysis. Serum alkaline phosphatases < 3/ULN.

15. Effective contraception method in patients and their couple.

16. Informed consent.

Exclusion Criteria:

1. Previous radiation or chemotherapy for the glioma´s treatment.

2. Less than 5 years time from any previous infiltrant neoplasia

3. Serious Cerebral haemorrhage after biopsy

4. Anticomital treatment inducting / inhibiting the CYP3A4 enzyme: fenitoin, carbamacepzin, phenobarbitone or other drugs that interact with sunitinib metabolism and that could not be replaced by another drug without interactions with Sunitinib.

5. Pregnancy or lactation.

6. Active or not controlled cardiovascular disease such as hypertension, angor instable, cardiac congestive failure IInd degree (NYHA), cardiac arrhythmia, previous myocardium heart attack, up to 1 year before the randomization

7. Currently treatment established with therapeutic doses of derivated anticoagulants of coumarin (coumarin, warfarin) or a week before the beginning of sunitinib. The administration of heparins of low molecular weight for TVP's control is allowed

8. Patient with TVP

9. HTA with higher values than 150/100 and not controllable with antihypertensive standard drugs

10. Not healed scars, sores or bone fractures

11. Hemorrhagic diathesis or coagulate illnesses