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LITT Followed by Hypofractionated RT for Recurrent Gliomas
RECRUITINGN/ASponsored by University of Maryland, Baltimore
Actively Recruiting
PhaseN/A
SponsorUniversity of Maryland, Baltimore
Started2020-01-08
Est. completion2026-12
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT04181684
Summary
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
Eligibility
Age: 22 Years+Healthy volunteers accepted
Inclusion Criteria: 1. Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor * Patient must have received prior radiation therapy for initial treatment of glioma * Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation 2. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration 3. History and physical including neurological exam within 30 days prior to registration 4. Karnofsky performance status ≥ 60% within 30 days prior to registration 5. Age ≥ 22 years old 6. Minimum interval since completion of prior radiation treatment is 8 weeks * Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor 7. Patients must have signed an approved informed consent 8. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion. 9. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration. Exclusion Criteria: 1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation 2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following: * History or presence of serious uncontrolled ventricular or significant arrhythmias. * Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism 3. Infratentorial tumor or evidence of leptomeningeal spread 4. Inability to undergo a MRI 5. Pregnant or breast-feeding women
Conditions5
Brain TumorCancerGlioblastomaGliomaNeoplasms
Locations4 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Mark Mishra, MD410-328-6080
UCH Kaufman Cancer Center
Bel Air, Maryland, 21014
Mark Mishra, MD410-328-6080
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Mark Mishra, MD410-328-6080
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Mark Mishra, MD410-328-6080
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Actively Recruiting
PhaseN/A
SponsorUniversity of Maryland, Baltimore
Started2020-01-08
Est. completion2026-12
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT04181684