LITT Followed by Hypofractionated RT for Recurrent Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04181684
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Maryland, Baltimore
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Brain Tumor, Glioma, Neoplasms

Additional Details

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.

Arms & Interventions

Arms

Experimental: Experimental: LITT with Hypofractionated radiation therapy

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.

Interventions

Device: - Procedure: LITT

This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.

Radiation: - Hypo-Fractionated Radiation Therapy

Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201

Site Contact

Mark Mishra, MD

[email protected]

410-328-6080

UCH Kaufman Cancer Center, Bel Air, Maryland

Status

Recruiting

Address

UCH Kaufman Cancer Center

Bel Air, Maryland, 21014

Site Contact

Mark Mishra, MD

[email protected]

410-328-6080

Central Maryland Radiation Oncology, Columbia, Maryland

Status

Recruiting

Address

Central Maryland Radiation Oncology

Columbia, Maryland, 21044

Site Contact

Mark Mishra, MD

[email protected]

410-328-6080

Baltimore Washington Medical Center, Glen Burnie, Maryland

Status

Recruiting

Address

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

Site Contact

Mark Mishra, MD

[email protected]

410-328-6080

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