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

NCT01508117

Last updated date
Study Location
University of Cincinnati
Cincinnati, Ohio, 45267-0502, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glioblastoma Multiforme
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
Official Title  ICMJE A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Axitinib
    5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
    Other Name: AG-013736
  • Radiation: Radiation Therapy
    45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
    Other Name: Hypofractionated radiation therapy
Study Arms  ICMJE Experimental: 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
Interventions:
  • Drug: Axitinib
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
68
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508117
Other Study ID Numbers  ICMJE UCCR-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rekha Chaudhary, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Rekha Chaudhury, MDUniversity of Cincinnati
PRS Account University of Cincinnati
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP