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

NCT01100177 | Completed Phase 2

• 1 other identifier: GENOM-008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Keywords

Patients with non resectable Glioblastoma who have only a; biopsy as surgical treatment

Outcome Measures

Primary Outcomes (1)

• Objective response rate to Sunitinib therapy

  Clinical activity in terms of clinical response (RANO criteria) after 2, 4 weeks cycles of Sunitinib treatment.

  8 weeks after treatment

Secondary Outcomes (4)

• Safety of Sunitinib with Radiation therapy

  14 weeks

• Assess the number of patients without neurological deterioration before radiation

  8 weeks

• Evaluation of progression free survival

  participants are followed until progression

• Overall survival

  participants are followed until death

Study Arms (1)

Sunitinib plus radiothery

EXPERIMENTAL

* Sunitinib at doses of 37.5mg/m2/daily in a continuous dosing during 8 weeks. * After evaluation of efficacy, they will receive Sunitinib 37.5 mg/d and treatment with Radiation therapy (total dose 60 Gy). * After radiation therapy, Sunitinib al 37.5 mg/d will be continued until progression.

Drug: Sunitinib; Radiation: Radiation

Interventions

Sunitinib DRUG

Sunitinib 37.5mg/m2/d

Sunitinib plus radiothery

Radiation RADIATION

Radiation therapy (60Gy) 2 Gy per day during 30 days

Sunitinib plus radiothery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with glioblastoma, non resectable, who have only a biopsy as surgical treatment.
• Measurable disease and with contrast capture of 2cm
• Performance status 0-1-2
• Age \< 75 years
• MMS \> 25/30
• Barthel index \> 50%
• Basal MRI done 3 weeks at the most before the beginning of the treatment which has specified conditions at the protocol.
• FEVI \> 50%
• Suitable medullar reserve (neutrophils \_2000x109/L, platelets \_ 100x109/L, Haemoglobin \_ 10 g/dl.)
• Not previous chemotherapy or radiation treatment.
• Creatinin \< 1,5 times the superior standard limit of the laboratory in charged of the analysis.
• 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.
• Effective contraception method in patients and their couple.
• Informed consent.

You may not qualify if:

• Previous radiation or chemotherapy for the glioma´s treatment.
• Less than 5 years time from any previous infiltrant neoplasia
• Serious Cerebral haemorrhage after biopsy
• 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.
• Pregnancy or lactation.
• 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
• 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
• Patient with TVP
• HTA with higher values than 150/100 and not controllable with antihypertensive standard drugs
• Not healed scars, sores or bone fractures
• Hemorrhagic diathesis or coagulate illnesses

Sponsors & Collaborators

• Grupo Español de Investigación en Neurooncología: lead

Study Sites (1)

Grupo Español de Investigacion en Neurooncologia

Madrid, Madrid, 28001, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Glioblastoma

Interventions

Sunitinib; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Physical Phenomena

Study Officials

• Carmen Balaña, Coordiantor

  Hospital Germans Trias i Pujol, Badalona, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 8, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

ES (1)