LITT Followed by Hypofractionated RT for Recurrent Gliomas

Neoplasms Clinical Trial

— GCCC 19140  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181684
• Other study ID #: HP-00088569
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Mark Mishra, MD
• Phone: 410-328-6080
• Email: mmishra[@]umm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioblastoma
• Glioma
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	UCH Kaufman Cancer Center	Bel Air	Maryland
United States	Central Maryland Radiation Oncology	Columbia	Maryland
United States	Baltimore Washington Medical Center	Glen Burnie	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Keep Punching Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.	2 years
Secondary	Progression-free survival at 6 months	To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy	2 Years
Secondary	Median progression-free survival	To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.	2 Years
Secondary	Median overall survival	To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.	2 years
Secondary	1-year overall survival	To describe 1 year overall survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.	2 years
Secondary	Overall response rate	To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.	2 years
Secondary	Quality of Life before, during, and after treatment	Patient reported quality of life impact from undergoing LITT followed by hypofractionated radiation therapy using the M.D. Anderson Symptom Inventory- Brain Tumor (MDASI-BT) questionnaire.	2 years