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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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

• Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration

• History and physical including neurological exam within 30 days prior to registration

• Karnofsky performance status ≥ 60% within 30 days prior to registration

• Age ≥ 22 years old

• 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

• Patients must have signed an approved informed consent

• 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.

• Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Locations
United States
Maryland
University of Maryland Greenebaum Cancer Center
RECRUITING
Baltimore
UCH Kaufman Cancer Center
RECRUITING
Bel Air
Central Maryland Radiation Oncology
RECRUITING
Columbia
Baltimore Washington Medical Center
RECRUITING
Glen Burnie
Contact Information
Primary
Mark Mishra, MD
mmishra@umm.edu
410-328-6080
Backup
Megan A Camara, RN
megan.camara@umm.edu
410-369-5355
Time Frame
Start Date: 2020-01-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 32
Treatments
Experimental: Experimental: LITT with Hypofractionated radiation therapy
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Sponsors
Collaborators: Keep Punching Foundation
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov