Glioblastoma Multiforme
Conditions
Keywords
GBM, brain tumor
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.
Interventions
DRUGAxitinib
5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
RADIATIONRadiation Therapy
45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Sponsors
Pfizer
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | average 1 year |
Countries
United States
Participant flow
Recruitment details
Recruitment period 8/10/11-10/26/12
Participants by arm
| Arm | Count |
|---|---|
| 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
Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Axitinib + Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Overall Survival
Time frame: average 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Radiation Therapy | Overall Survival | 0.2 years |