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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Metastasis

Intervention / Treatment
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* Drug: Trental
* Dietary Supplement: Vitamin E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trental + Vitamin E<br>Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment | Drug: Trental<br>* 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months<br>* Other names: Pentoxifylline;Dietary Supplement: Vitamin E<br>* 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Symptomatic Radiation Necrosis | Number of symptomatic death of healthy tissue caused by radiation therapy. | average 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain metastasis