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New treatment option for Recurrent Glioblastoma
Official title Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT06910306
What this study is testing
- What it's testing
- A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Males and females ≥ 18 and ≤ 85 years of age
- Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).
- Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter
- Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically...
- Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent...
You likely can't join if
- Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)
- More than 3 relapses per RANO criteria
- Acquired and or genetic clinical bleeding tendency
- Suspicious of infratentorial or leptomeningeal or intraventricular disease
- Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
- Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor
See the full eligibility criteria
- Males and females ≥ 18 and ≤ 85 years of age
- Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).
- Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter
- Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and/or eloquent location.
- Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or...
- Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria
- Patients must have a measurable disease per RANO criteria
- Estimated life expectancy is more than 6 months
- Target lesion amenable for coverage by the DaRT sources
- Patient must either have had recent subtotal surgery/biopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by...
- Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine...
- Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration
- Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet...
- Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN
- Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment
- Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities
- Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)
- More than 3 relapses per RANO criteria
- Acquired and or genetic clinical bleeding tendency
- Suspicious of infratentorial or leptomeningeal or intraventricular disease
- Concomitant chemotherapy or any other systemic therapy not allowed in the protocol
- Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor
- Immunocompromised state due to either transplant or AIDS
- Prior allergic reaction to the study drugs
- History of hypertensive crisis or hypertensive encephalopathy
- Uncontrolled hypertension (defined as either \>150 mm/Hg for systolic and \>90mm/Hg for diastolic)
- History of a non-healing wound, ulcer, gastrointestinal bleed (\> grade 3), traumatic injury, or bone fracture within 90 days prior to registration Volunteers participating in another treatment study in the past 30 days...
- High probability of protocol non-compliance (in opinion of investigator)
- Pregnancy or lactation
- Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- New York, New York, United States
- Columbus, Ohio, 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, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; New York, New York, United States; Columbus, Ohio, 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.