Trial Information
A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophalaxis of Radiation Necrosis
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
incidence of symptomatic radiation necrosis
Outcome Time Frame:
average 1 year
Safety Issue:
No
Principal Investigator
Ronald Warnick, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cincinnati
Authority:
United States: Institutional Review Board
Study ID:
BTC-W1
NCT ID:
NCT01508221
Start Date:
June 2011
Completion Date:
June 2015
Related Keywords:
- Brain Metastasis
- brain metastasis
- Necrosis
- Neoplasm Metastasis
- Brain Neoplasms
Name | Location |
University of Cincinnati |
Cincinnati, Ohio 45267-0502 |