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Spots Global Cancer Trial Database for 5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

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Trial Identification

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

Interventions

Temozolomide

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Lawrence Kleinberg, MD

Affiliation: SKCCC at Johns Hopkins (East Baltimore)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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