Temozolomide in Elderly Patients With KPS < 70

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise; Association de Neuro-Oncologues d’Expression Francaise
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histologically confirmed supratentorial glioblastoma

• Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy

• Patients aged 70 years or older

• KPS above 30 and below 70

• Life expectancy higher than 4 weeks

• Clinical examination at baseline

• Affiliation to Social Security or mandatory beneficiary

• Patient being informed and obtention of written informed consent

Exclusion Criteria:

• Prior surgical resection dated more than 1 month before inclusion

• Prior brain radiotherapy or chemotherapy

• Severe underlying disease which could interfere with survival

• History of hypersensibility reaction on temozolomide components

• Severe bone marrow hypoplasia

• Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal

• Absolute neutrophil count < 1.5x109 cells per liter

• Platelet count < 100x109 cells per liter

• Hemoglobin < 9 g/dl

• Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy