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

NCT ID: NCT01508117

Last Updated: 2017-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axitinib + 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

Group Type EXPERIMENTAL

Axitinib

Intervention Type DRUG

5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Radiation Therapy

Intervention Type RADIATION

45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Interventions

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Axitinib

5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Intervention Type DRUG

Radiation Therapy

45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Intervention Type RADIATION

Other Intervention Names

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AG-013736 Hypofractionated radiation therapy

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Rekha Chaudhary

Adjunct Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rekha Chaudhury, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UCCR-2

Identifier Type: -

Identifier Source: org_study_id