A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis

BTC-W1

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.

2011-06-01

2017-02-01

2017-02-01

Completed

Early phase I

31

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

2023-09-14