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| Name | Class |
|---|---|
| Keep Punching Foundation | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: LITT with Hypofractionated radiation therapy | Experimental | Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: LITT | Device | This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 Years |
| Median progression-free survival |
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Inclusion Criteria:
Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
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 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:
Infratentorial tumor or evidence of leptomeningeal spread
Inability to undergo a MRI
Pregnant or breast-feeding women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Mishra, MD | Contact | 410-328-6080 | mmishra@umm.edu | |
| Megan A Camara, RN | Contact | 410-369-5355 | megan.camara@umm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Greenebaum Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| Hypo-Fractionated Radiation Therapy | Radiation | 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. |
|
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.
| 2 Years |
| 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. | 2 years |
| 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. | 2 years |
| 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. | 2 years |
| 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. | 2 years |
| UCH Kaufman Cancer Center | Recruiting | Bel Air | Maryland | 21014 | United States |
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| Central Maryland Radiation Oncology | Recruiting | Columbia | Maryland | 21044 | United States |
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| Baltimore Washington Medical Center | Recruiting | Glen Burnie | Maryland | 21061 | United States |
|
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |