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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
186RNL
DrugIntraventricular injection via catheter. Patients will be assigned to three separate dosing schedules and once assigned they will remain on that dose level for up to 12 months (6 doses). Each dose will be 26.4 mCi, and participants will receive three doses for a total of 79.2 mCi. The time between doses will vary depending on the schedule (shown in table 1): * Schedule 1: Every 56 days * Schedule 2: Every 28 days * Schedule 3: Every 14 days
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: WBRT or PCSI followed by REYOBIQExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLTs)
The incidence of DLTs during the 28-day DLT window following any administration of REYOBIQ.
Time frame
Up to Month 13 (28 Days Post-Final Dose)Secondary outcomes
1
Central Nervous System Progression-Free Survival (CNS PFS)
Defined as the time from first treatment to the date of leptomeningeal metastases (LM) progression or death from any cause, whichever occurs first.
Time frame
Up to Year 52
Overall Survival (OS)
Defined as the time from first treatment to death from any cause.
Time frame
Up to Year 53
Overall Response Rate (ORR)
Defined as the proportion of evaluable patients achieving a best overall response (complete or partial response) prior to progression.
Time frame
Up to Year 54
Duration of Response (DoR)
Defined as the time from first treatment to the date of LM progression among responders.
Time frame
Up to Year 5Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: