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Brief Title: 5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme
Official Title: A Pilot Study to Assess Feasibility of 5 Fraction Hypofractionated Stereotactic Radiosurgery Along With Standard Temozolomide as a Lymphocyte Sparing Therapy for Glioblastoma Multiforme
Study ID: NCT03291990
Brief Summary: This investigation is not only to develop an improved radiation/temozolomide approach, but also develop a regimen with potential to form the basis of better combined therapy with immune based treatments.
Detailed Description: Glioblastoma has a poor prognosis with median survival is 14-16 months for patients enrolling in clinical trials, and across the United States one year survival is reported in the Surveillance, Epidemiology, and End Results (SEER) registry to be only 35%. Radiation treatment related lymphopenia has been associated with poor tumor outcome in Glioblastoma and a variety of other tumor types. As this lymphopenias is prolonged, it may also reduce efficacy of the checkpoint inhibitor lymphocyte mediated immune therapies now approved by the FDA for an increasing number of indications. Modeling and clinical studies suggest that administering radiation over 5 or fewer days (rather than standard 30 days of treatment) may reduce the incidence of lymphopenia.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sibley Hospital, Washington, District of Columbia, United States
Suburban Hospital, Washington, District of Columbia, United States
SKCCC at Johns Hopkins (East Baltimore), Baltimore, Maryland, United States
Name: Lawrence Kleinberg, MD
Affiliation: SKCCC at Johns Hopkins (East Baltimore)
Role: PRINCIPAL_INVESTIGATOR