Using laser therapy followed by targeted radiation for recurrent brain tumors
Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
This study is testing a new treatment that uses laser therapy followed by targeted radiation to see if it helps people with recurring brain tumors feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Baltimore, Maryland and 3 other locations) |
| Trial ID | NCT04181684 on ClinicalTrials.gov |
What this trial studies
This study evaluates a treatment regimen combining Laser Interstitial Thermal Therapy (LITT) with Hypo-fractionated Radiation Therapy for patients with recurrent gliomas. LITT serves as a minimally invasive alternative to surgical resection, allowing for immediate initiation of radiation therapy while also providing a tissue diagnosis of the recurrent tumor. The study aims to assess the effectiveness of this combined approach in managing recurrent glioblastoma and other gliomas.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22 and older with a history of WHO Grade II-IV gliomas who have evidence of recurrent tumors and have not undergone re-irradiation.
Not a fit: Patients with gliomas who have already received re-irradiation or those with tumors larger than 6 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, less invasive option for patients with recurrent gliomas, potentially improving outcomes and quality of life.
How similar studies have performed: Other studies have shown promise in using LITT for brain tumors, suggesting that this combined approach may be a novel yet potentially effective treatment.
Eligibility criteria
Show full inclusion / exclusion 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 ≥ 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
Where this trial is running
Baltimore, Maryland and 3 other locations
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States (Recruiting)
- UCH Kaufman Cancer Center — Bel Air, Maryland, United States (Recruiting)
- Central Maryland Radiation Oncology — Columbia, Maryland, United States (Recruiting)
- Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Mark Mishra, MD
- Email: mmishra@umm.edu
- Phone: 410-328-6080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.