Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Roche Pharma AG
• Treatments: Bevacizumab; Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Supratentorial Glioblastoma diagnosed by biopsy.

• Patients aged ≥ 70 years

• KPS >30 and < 70

• Life expectancy > or = 8 weeks

• Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy.

• CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage.

• Included to health social security system

• Medical assessment previous to inclusion

• Informed consent form

Exclusion Criteria:

• Previous treatment with Surgical resection, RT or chemotherapy to the tumor.

• Hemoglobin level < 9 g%

• Absolute neutrophil count < 1500

• Platelet count < 100.000

• ASAT or ALAT levels more than 3 times the upper limit of normal.

• Bilirubin levels more than 2 times the upper limit of normal

• Creatinin more than 1.5 times the upper limit of normal

• Untreated high blood pressure >150/100 mmHg

• Congestive cardiac failure

• Proteinuria > 1 gr/24h

• INR > 1.5 the upper limit of normal

• Recent symptomatic haemorrhage

• History of abnormal wound healing

• Gastrointestinal fistula

• Haemoptysis > grade 2 (NCI-CTC)

• Intracranial abscess

• Coagulation disorder

• Active infection requiring intravenous antibiotics

• Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months

• Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer)

• Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.