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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Ronald Warnick, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01508221
First received: January 8, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Brain Metastasis
Drug: Trental
Dietary Supplement: Vitamin E
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • incidence of symptomatic radiation necrosis [ Time Frame: average 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trental + Vitamin E
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Drug: Trental
400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
Other Name: Pentoxifylline
Dietary Supplement: Vitamin E
400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Other Name: Vitamin E

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508221

Contacts
Contact: UC Cancer Institute 513-584-7698

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute    513-584-7698      
Principal Investigator: Ronald Warnick, MD         
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Ronald Warnick, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Ronald Warnick, Medical Director, University of Cincinnati Brain Tumor Center, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01508221     History of Changes
Other Study ID Numbers: BTC-W1
Study First Received: January 8, 2012
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
brain metastasis

Additional relevant MeSH terms:
Necrosis
Neoplasm Metastasis
Brain Neoplasms
Pathologic Processes
Neoplastic Processes
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pentoxifylline
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014