Active — Not RecruitingPhase 1

Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

United States18 participantsStarted 2021-12-06

Plain-language summary

This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. At least 18 years of age at time of 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.
✓. Subject has proven and documented LM that meets the requirements for the study:
✓. Karnofsky performance status of 60 to 100.
✓. Acceptable liver function:
✓. Acceptable hematologic status (without hematologic support):
✓. All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.
✓. Subjects with a creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation) for males and females.

Exclusion criteria

✕. The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) 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.
✕. Obstructive or symptomatic communicating hydrocephalus.
✕. Ventriculo-peritoneal or ventriculo-atrial shunts without programable valves 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, such as progressive systemic (extra leptomeningeal) disease, 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.
✕. Active severe non hematologic organ toxicity such as renal, cardiac, hepatic, pulmonary, or gastrointestinal systemic toxicity grade 3 or above.
✕. Significant coagulation abnormalities such as inherited bleeding diathesis or acquired coagulopathy with unacceptable risks of bleeding.
✕. Patients who had any dose to the spinal cord or whole brain radiation therapy, regardless of when the radiation treatment was delivered. Prior, non-CNS radiation for primary tumor is allowed.

What they're measuring

Incidence and severity of adverse events (AE) and serious adverse events (SAE)

Timeframe: 12 months

Incidence of dose-limiting toxicities (DLT)

Timeframe: 12 months

Trial details

NCT IDNCT05034497

SponsorPlus Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-21

View on ClinicalTrials.gov More Leptomeningeal Metastasis trials