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

NCT01508221 | Completed Phase 2 Results

• 1 other identifier: BTC-W1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastasis

Keywords

brain metastasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Symptomatic Radiation Necrosis

  Number of symptomatic death of healthy tissue caused by radiation therapy.

  average 1 year

Study Arms (1)

Trental + Vitamin E

EXPERIMENTAL

Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment

Drug: Trental; Dietary Supplement: Vitamin E

Interventions

Trental DRUG

400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months

Also known as: Pentoxifylline

Trental + Vitamin E

Vitamin E DIETARY_SUPPLEMENT

400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months

Trental + Vitamin E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Pentoxifylline; Vitamin E

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Alison Kastl
• Organization: University of Cincinnati

Kastla@ucmail.uc.edu

513-584-0436

Study Officials

• Ronald Warnick, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, University of Cincinnati Cancer Center

Study Record Dates

• First Submitted: January 8, 2012
• First Posted: January 11, 2012
• Study Start: June 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)