Brain Metastasis
Conditions
Keywords
brain metastasis
Brief summary
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
Detailed description
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
Interventions
DRUGTrental
400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
DIETARY_SUPPLEMENTVitamin E
400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor * Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer * Age \> 18 years * Partial or total resection of a metastatic tumor are eligible
Exclusion criteria
* Known sensitivity to vitamin E or Trental * Recent intracranial bleed or retinal hemorrhage * Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment * History of Avastin treatment * Anticipated need for treatment with Avastin * History of bleeding disorder * History of liver disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic Radiation Necrosis | average 1 year | Number of symptomatic death of healthy tissue caused by radiation therapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trental + Vitamin E Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Trental: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
Vitamin E: 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Trental + Vitamin E |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 56.87 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 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 | 29 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 31 |
| other Total, other adverse events | 4 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Number of Participants With Symptomatic Radiation Necrosis
Number of symptomatic death of healthy tissue caused by radiation therapy.
Time frame: average 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trental + Vitamin E | Number of Participants With Symptomatic Radiation Necrosis | 1 Participants |