Brain Tumor, Glioblastoma, Glioma, Neoplasms
Conditions
Keywords
Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
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.
Interventions
DEVICEProcedure: LITT
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
RADIATIONHypo-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.
Sponsors
University of Maryland, Baltimore
Keep Punching Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival at 6 months | 2 Years | To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy |
| Median progression-free survival | 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. |
| Median overall survival | 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. |
| 1-year overall survival | 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. |
| Overall response rate | 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. |
| Quality of Life before, during, and after treatment | 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. |
Countries
United States
Outcome results
None listed