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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Metastasis

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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 CincinnatiCincinnati, Ohio  45267-0502