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Winthrop University Hospital

Phase II Trial of Temozolomide in Adults with Newly Diagnosed Glioblastomas

Summary

The purpose of this study is to see if using hyperbaric oxyen to sensatize glioblasomas to radiation prolongs median survival time. A secondary objective is to determine health related quality of life with this treatment protocol.

Description

Patients receive hyperbaric oxygen for 30 minutes at 3.0 ATA treatment prior to receiving radiation therapy while taking Temozolomide. The rationale is based on the fact that solid tissue tumors are hypoxic and radiaiton therapy requires oxygen to form free radicals. Based on previous studies there has been a positive effect when using hyperbaric oxygen to sensitize tumors to radiation.

Inclusion/exclusion

Greater than/equal to 18 years old; histologically confimed newly diagonsw WHO IV glioblastoma/gliosarcoma;patients are eligible postoperatively following biopsy, subtotal or gross total resction with or without radiographic evidence of residual disease;recent contrast-enhanced MRI within 4 weeks of enrollment onto protocol; no prior or concurrent antitumor therapy; Karnofsky performance score >= 60;no significant comorbidities; signed informed consent; adequate bone marrow function;adquate liver function and renal funcion; males, females and minorites are eligible without and preference to gender or race; negative serum pregnancy test

Principal Investigator

J. Paul Duic MD, Jai Greawal MD, Scott Gorenstein MD, Jonathan Haas MD

Email

sgorenstein@winthorp.org
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