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

Phase 2

Terminated

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Axitinib; Radiation: Radiation Therapy

• Registration Number: NCT01508117
• Lead Sponsor: University of Cincinnati

Brief 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-12
• Results First Submitted: 2017-08-18
• Results First Submitted QC: 2017-08-18
• Last Update Submitted: 2017-08-18
• Results First Posted: 2017-09-19
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axitinib + Radiation Therapy	Radiation Therapy	Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity
Axitinib + Radiation Therapy	Axitinib	Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity

Primary Outcome Measures

Name	Time	Method
Overall Survival	average 1 year

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States