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

Primary Purpose

Glioblastoma, Brain Tumor, Glioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procedure: LITT
Hypo-Fractionated Radiation Therapy
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Greenebaum Cancer CenterRecruiting
  • UCH Kaufman Cancer CenterRecruiting
  • Central Maryland Radiation OncologyRecruiting
  • Baltimore Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: LITT with Hypofractionated radiation therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.

Full Information

First Posted
November 24, 2019
Last Updated
May 2, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Keep Punching Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04181684
Brief Title
LITT Followed by Hypofractionated RT for Recurrent Gliomas
Acronym
GCCC 19140
Official Title
Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Keep Punching Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Brain Tumor, Glioma, Neoplasms
Keywords
Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: LITT with Hypofractionated radiation therapy
Arm Type
Experimental
Arm Description
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Intervention Type
Device
Intervention Name(s)
Procedure: LITT
Other Intervention Name(s)
Laser Interstitial thermal therapy
Intervention Description
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
Intervention Type
Radiation
Intervention Name(s)
Hypo-Fractionated Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival at 6 months
Description
To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy
Time Frame
2 Years
Title
Median progression-free survival
Description
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.
Time Frame
2 Years
Title
Median overall survival
Description
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.
Time Frame
2 years
Title
1-year overall survival
Description
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.
Time Frame
2 years
Title
Overall response rate
Description
To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Time Frame
2 years
Title
Quality of Life before, during, and after treatment
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients that are not surgical candidates for stereotactic biopsy or laser ablation 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 Infratentorial tumor or evidence of leptomeningeal spread Inability to undergo a MRI Pregnant or breast-feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Mishra, MD
Phone
410-328-6080
Email
mmishra@umm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan A Camara, RN
Phone
410-369-5355
Email
megan.camara@umm.edu
Facility Information:
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Megan Camara
Phone
410-369-5226
Facility Name
UCH Kaufman Cancer Center
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Caitlin Eggleston
Email
caitlineggleston@umm.edu
Facility Name
Central Maryland Radiation Oncology
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Caitlin Eggleston
Email
caitlineggleston@umm.edu
Facility Name
Baltimore Washington Medical Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mishra, MD
Phone
410-328-6080
First Name & Middle Initial & Last Name & Degree
Pilar Strycula
Email
P.Strycula@umm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LITT Followed by Hypofractionated RT for Recurrent Gliomas

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