Phase 1 Study of WBRT or PCSI With REYOBIQ for Leptomeningeal Metastases
ConditionLeptomeningeal Metastases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
This Phase 1 study is designed to assess the safety, tolerability, and schedule feasibility of administering Rhenium-186 NanoLiposome (REYOBIQ) at different dosing intervals following whole brain radiotherapy (WBRT) or proton craniospinal irradiation (PCSI).
Eligibility criteria
Qualifiers
At least 18 years of age at screening
Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB
Proven and documented LM evidenced by positive CSF cytology or CSF circulating tumor cells, from any primary solid tumor
Patients may have received prior chemotherapy regimens and prior radiation (there is no limit)
Disqualifiers
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v6.0) Grade ≤ 1 from AEs due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study. Prior AEs due to alopecia, anemia, and lymphopenia are not required to be recovered to Grade ≤ 1 prior to 186RNL treatment, assuming other inclusion criteria are satisfied.
Ventriculo-peritoneal or ventriculo-atrial shunts or contraindications to placement of Ommaya reservoir.
Females of childbearing potential who are pregnant, breast feeding, or may possibly be pregnant without a negative serum pregnancy test (see inclusion criteria).
Serious intercurrent illness, clinically significant cardiac arrhythmias, uncontrolled systemic infection, symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug, myocardial infarction, stroke, transient ischemic attack within 6 months, seizure disorder with any seizure occurring within 14 days prior to consenting or encephalopathy.
Trial design
Treatments tested in this trial
- 186RNL
Treatment groups
29 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov