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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

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:

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

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

NCT ID

NCT04181684

First Posted

November 24, 2019

Last Updated

May 2, 2023

Sponsor

University of Maryland, Baltimore

Collaborators

Keep Punching Foundation

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

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

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

mmishra@umm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Megan A Camara, RN

Phone

410-369-5355

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

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

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

P.Strycula@umm.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

LITT Followed by Hypofractionated RT for Recurrent Gliomas

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