LITT Followed by Hypofractionated RT for Recurrent Gliomas (GCCC 19140)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Neoplasms; Glioblastoma; Brain Tumor
• Intervention / Treatment: Device: Procedure: LITT; Radiation: Hypo-Fractionated Radiation Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan A Camara, RN; Phone Number: 410-369-5355; Email: megan.camara@umm.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Greenebaum Cancer Center
      • Contact: Megan Camara; Phone Number: 410-369-5226
    • Bel Air, Maryland, United States, 21014
      • Recruiting
      • UCH Kaufman Cancer Center
    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Central Maryland Radiation Oncology
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • Baltimore Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Procedure: LITT; This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.; Other Names: Laser Interstitial thermal therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Keep Punching Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioblastoma; Glioma; Brain Neoplasms
• Other Study ID Numbers: HP-00088569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes