Loading clinical trials...

TERMINATEDPHASE2

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

A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)

NCT01508117•University of Cincinnati

View on ClinicalTrials.gov

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.

Detailed Description

The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

September 19, 2017

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme

Interventions

Axitinib

DRUG

Radiation Therapy

RADIATION

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Study of Pembrolizumab and M032 (NSC 733972)

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma