BridgeMD
Tests treatment safety and results for Low-grade Glioma
Official title Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma
ClinicalTrials.gov ID: NCT07506239
What this study is testing
- What it's testing
- This study aims to evaluate the efficacy of Laser Interstitial Thermal Therapy (LITT) in treating recurrent or progressive, low-grade gliomas (LGG) in pediatric, adolescent and young adult patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25
You may be able to join if
- Participants must have recurrent or progressive pediatric LGG who have received at least one prior treatment. Prior treatment may include surgery...
- Participants must have histologically confirmed LGG that is recurrent or progressive after prior treatment and determined to be a candidate for LITT...
- Tumor size: up to 5 cm in largest dimension not including any cystic component. Larger tumors will need to be discussed with the study team...
- Suprasellar gliomas not arising from the optic pathway are eligible.
- Multifocal or metastatic LGGs are eligible, provided that the growing lesions are suitable for LITT.
You likely can't join if
- Any contraindication to the use of LITT, such as but not limited to:
- Optic pathway gliomas
- Spinal tumors
- Brainstem Lesions: Infiltrative brainstem lesions are excluded. However, exophytic brainstem lesions, which are more accessible and present a lower...
- Any lesion/location determined by central review to be contraindicated for LITT.
- The presence of uncontrolled leptomeningeal disease or extracranial disease including:
See the full eligibility criteria
Who can join
- Participants must have recurrent or progressive pediatric LGG who have received at least one prior treatment. Prior treatment may include surgery alone and/or systemic therapy.
- Participants must have histologically confirmed LGG that is recurrent or progressive after prior treatment and determined to be a candidate for LITT by central review. All patients will undergo central review prior to...
- Tumor size: up to 5 cm in largest dimension not including any cystic component. Larger tumors will need to be discussed with the study team. Additional adjunctive interventions such as cyst aspiration prior to or...
- Suprasellar gliomas not arising from the optic pathway are eligible.
- Multifocal or metastatic LGGs are eligible, provided that the growing lesions are suitable for LITT.
- Exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.
- A patient with stable leptomeningeal disease and a separate growing lesion suitable for LITT is eligible for the study.
- Prior Therapy: Participants may have had LITT for other medical indications, provided that the lesion being considered for this study has not previously undergone LITT, except for patients who have received LITT for an...
- Participants must have fully recovered from the acute toxic effects of all prior chemotherapy or targeted therapy prior to entering this study and would be eligible for surgical intervention per institutional guidelines.
- Bevacizumab: participants must have received last dose \> 21 days prior to study registration.
- Participants must have had chemotherapy \> 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior...
- Radiation: Participants must have:
- Had their last fraction of local irradiation or focal radiosurgery to primary tumor ≥12 weeks prior to registration.
- Had their last fraction of craniospinal irradiation or total body irradiation ≥ 12 weeks prior to registration
- Age \>= 2 years to \<= 25 years of age
- Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be...
- Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
- Patients must be surgically eligible per institutional standards.
- Patients must co-enroll to Pediatric Neuro-oncology Consortium (PNOC) COMP if PNOC COMP is open to accrual at the enrolling institution.
- A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
What rules you out
- Any contraindication to the use of LITT, such as but not limited to:
- Optic pathway gliomas
- Spinal tumors
- Brainstem Lesions: Infiltrative brainstem lesions are excluded. However, exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.
- Any lesion/location determined by central review to be contraindicated for LITT.
- The presence of uncontrolled leptomeningeal disease or extracranial disease including:
- Evidence of untreated obstructive hydrocephalus or mass effect causing \>10 millimeter (mm) midline shift
- Presence of symptomatic intratumoral hemorrhage (Grade 3 \& 4). Intratumoral hemorrhage grade 2 needs to be discussed with study team.
- Participants who are receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection. Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.