Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis

University of Cincinnati

Status and phase

Completed

Phase 2

Conditions

Brain Metastasis

Treatments

Drug: Trental

Dietary Supplement: Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT01508221

BTC-W1

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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