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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Glioblastoma; Glioma; Neoplasms; Brain Tumor

Treatments: Radiation: Hypo-Fractionated Radiation Therapy; Device: Procedure: LITT

Study type: Interventional

Funder types: Other

Identifiers

NCT04181684

HP-00088569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Experimental: LITT with Hypofractionated radiation therapy

Experimental group

Description:

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

Treatment:

Device: Procedure: LITT

Radiation: Hypo-Fractionated Radiation Therapy