Progressive/Recurrent Intracranial Meningioma Treated With SSTR-Targeted Alpha Emitter RYZ101 (PRIMe-STAR)
Joshua Palmer
Summary
This phase I/II tests the safety, side effects, best dose and how well giving RYZ101 works for the treatment of patients with intracranial meningioma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). RYZ101 is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving RYZ101 may be safe, tolerable and/or effective in treating patients with progressive or recurrent intracranial meningioma.
Description
PRIMARY OBJECTIVE: I. To estimate the efficacy of 225Ac-DOTATATE (RYZ101) therapy in the treatment of patients with progressive or recurrent grade 1-3 intracranial meningioma as measured by the progression free survival at 6 months. SECONDARY OBJECTIVES: I. To evaluate the objective response rate (ORR) by standard of care brain magnetic resonance imaging (MRI) at 6 months and gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography (PET) imaging at 1 year. II. To determine the overall survival (by grade cohort) in patients with progressive / recurrent meningioma during or after…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients of age \> 18 years * Patients with 68Ga-DOTATATE positive recurrent or progressive meningiomas, any World Health Organization (WHO) grade, who have progressed after first line treatment. * For Grade I meningioma, patients must have either: * Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 12 months; or * Progressive residual tumor after maximal safe resection,…
Interventions
- DrugActinium Ac 225 DOTATATE RYZ101
Given IV
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureEchocardiography Test
Undergo echocardiography
- RadiationGallium Ga 68-DOTATATE
Given IV
- DrugL-lysine/L-arginine-containing Amino Acid
Given IV
- ProcedureMagnetic Resonance Imaging
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio