Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

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

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Pfizer
• Treatments: Axitinib

Criteria

Inclusion Criteria:

• Newly diagnosed patients with histologically proven glioblastoma multiforme

• Age above 70 years

• Karnofsky score of 50-80

• Adequate organ function as defined by laboratory values

• Life expectancy of >12 weeks

• No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.

Exclusion Criteria:

• Prior treatment with chemotherapy or radiation for glioblastoma multiforme

• Patients with extensive tumor hemorrhage

• Any of the following within the 12 months prior to study drug administration:

myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism