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

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Axitinib
Radiation Therapy
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring GBM, brain tumor

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axitinib + Radiation Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Full Information

First Posted
January 6, 2012
Last Updated
August 18, 2017
Sponsor
University of Cincinnati
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01508117
Brief Title
Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Official Title
A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
transferred study sponsor
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
GBM, brain tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axitinib + Radiation Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Axitinib
Other Intervention Name(s)
AG-013736
Intervention Description
5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Hypofractionated radiation therapy
Intervention Description
45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
average 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Chaudhury, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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