Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-10-27
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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177Lu-PSMA-617
Patients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression.
Temozolomide
Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.
177Lu-PSMA-617
This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.
68Ga-PSMA-PET scan/ MRI
Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
Quality of Life Questionnaires
baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment
Interventions
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Temozolomide
Patients will begin taking Temozolomide orally on the first 5 days of each 28-day cycle. The first dose will be given the evening before the first infusion of 177Lu-PSMA- 617.
177Lu-PSMA-617
This agent will be given for 2-6 total doses, spaced 4 weeks (+/-1 week) apart. This will be administered on the 2nd day of the first two cycles of SOC adjuvant temozolomide.
68Ga-PSMA-PET scan/ MRI
Approximately 4 weeks after cycle 2 of radiopharmaceutical therapy (RPT), patients will undergo post-treatment imaging with 68Ga- PSMA PET and MRI
Quality of Life Questionnaires
baseline assessments, QOL surveys will be conducted with XeQOL and FACT-Br at 6 months and 12 months post treatment
Eligibility Criteria
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Inclusion Criteria
* Diffuse astrocytoma, IDH-wildtype (grade 2-4)
* Glioblastoma, IDH-wildtype
* Diffuse midline glioma, H3 K27-altered
* Diffuse hemispheric glioma, H3 G34-mutant
* Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample
* Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma
* Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical
* Age ≥ 18
* ECOG ≤ 2
* Serum creatinine level \< 1.5 x ULN or EGFR \> 60 mL/min
* Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin \> 2 g/ dL; Bilirubin \< 3 X ULN
* Normal organ and marrow function as defined as the following
* Total white blood count \> 3.0 K/mcL
* ANC ≥ 1.5 K/mcL
* Platelets ≥ 100 K/mcL
* Hemoglobin ≥ 9 g/dL
* Adequate contraception prior to registration (see section 9.0)
* Ability to understand, and willingness to sign the informed consent.
Exclusion Criteria
* Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
* Life expectancy less than 12 weeks
* Nonhealing wound, ulcer or bone fracture
* History of severe brain injury
* Patient not eligible for sequential MRI evaluations
* Patients with prior RT to \> 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Patients with known or suspected history of grade II or higher chronic kidney disease (CKD)
* Unable to tolerate the PSMA PET/MR or PSMA PET/CT
* History of viral hepatitis or chronic liver disease with active symptoms
* History of pituitary or adrenal dysfunction
* Previously diagnosed active infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis)
* Any condition that in the opinion of the investigator, would preclude participation in this study
* Receipt of any other investigational agents or participation in a concurrent treatment protocol
* Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11/177Lu-PSMA-617 or its inactive compounding components
* Current or planned pregnancy
* Refusal to comply with detailed contraception requirements
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brandon Imber, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Thomas Kaley, MD
Role: CONTACT
Facility Contacts
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Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-169
Identifier Type: -
Identifier Source: org_study_id
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