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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181684
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Keep Punching Foundation
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Brain Tumor Glioma Neoplasms Device: Procedure: LITT Radiation: Hypo-Fractionated Radiation Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
Actual Study Start Date : January 8, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 2 years ]
    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 :
  1. Progression-free survival at 6 months [ Time Frame: 2 Years ]
    To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy

  2. Median progression-free survival [ Time Frame: 2 Years ]
    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.

  3. Median overall survival [ Time Frame: 2 years ]
    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.

  4. 1-year overall survival [ Time Frame: 2 years ]
    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.

  5. Overall response rate [ Time Frame: 2 years ]
    To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.

  6. Quality of Life before, during, and after treatment [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 70% 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181684


Contacts
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Contact: Mark Mishra, MD 410-328-6080 mmishra@umm.edu
Contact: Jasmine A Newman, BS 410-369-5355 jasmine.newman@umm.edu

Locations
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United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark Mishra, MD    410-328-6080      
Contact: Jasmine Newman    410-369-5226      
UCH Kaufman Cancer Center Not yet recruiting
Bel Air, Maryland, United States, 21014
Contact: Mark Mishra, MD    410-328-6080      
Contact: Linda Romar       lromar@umm.edu   
Central Maryland Radiation Oncology Recruiting
Columbia, Maryland, United States, 21044
Contact: Mark Mishra, MD    410-328-6080      
Contact: Caitlin Eggleston       caitlineggleston@umm.edu   
Baltimore Washington Medical Center Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Mark Mishra, MD    410-328-6080      
Contact: Pilar Strycula       P.Strycula@umm.edu   
Sponsors and Collaborators
University of Maryland, Baltimore
Keep Punching Foundation

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Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT04181684    
Other Study ID Numbers: HP-00088569
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Department of Radiation Oncology, University of Maryland, Baltimore:
Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Glioblastoma
Glioma
Astrocytoma
Brain Diseases
Nervous System Diseases