RECRUITING

LITT Followed by Hypofractionated RT for Recurrent Gliomas

Conditions

Glioblastoma Brain Tumor Glioma Neoplasms Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.

Quick Facts

Study Start:2020-01-08

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04181684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Mark Mishra, MD

CONTACT

410-328-6080

mmishra@umm.edu

Megan A Camara, RN

CONTACT

410-369-5355

megan.camara@umm.edu

Study Locations (Sites)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

UCH Kaufman Cancer Center

Bel Air, Maryland, 21014

United States

Central Maryland Radiation Oncology

Columbia, Maryland, 21044

United States

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-08

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-01-08

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma

Additional Relevant MeSH Terms

Glioblastoma
Brain Tumor
Glioma
Neoplasms