Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
NCT01508117
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Adult Trials: 18+ Years
- 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.
- 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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| 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 |
| |||
| 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:
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| 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 | 1 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||