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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by University of Cincinnati
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Olivier Rixe, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01508117
First received: January 6, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: Axitinib
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • overall survival [ Time Frame: average 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508117

Contacts
Contact: UC Cancer Institute 513-584-7698

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0502
Contact: UC Cancer Institute    513-584-7698      
Principal Investigator: Olivier Rixe, MD, PhD         
Sponsors and Collaborators
University of Cincinnati
Pfizer
Investigators
Principal Investigator: Olivier Rixe, MD, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Olivier Rixe, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01508117     History of Changes
Other Study ID Numbers: UCCR-2
Study First Received: January 6, 2012
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
GBM
brain tumor

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 26, 2014