Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
This study is currently recruiting participants.
Verified January 2012 by University of Cincinnati
Sponsor:
University of Cincinnati
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
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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
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 May 21, 2013