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New treatment option for Leptomeningeal Metastasis
Official title Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
ClinicalTrials.gov ID: NCT07098806
What this study is testing
What is 186RNL?
186RNL is an investigational medicine, being studied as a potential treatment for leptomeningeal metastasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age.
- Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
- Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).
- Karnofsky performance status of 70 to 100.
- Acceptable liver function:
You likely can't join if
- The subject has not recovered to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤1...
- Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
- Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
- Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see...
- Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
- Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except:
See the full eligibility criteria
- At least 18 years of age.
- Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
- Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).
- Karnofsky performance status of 70 to 100.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times the upper limit of normal.
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for people with normal liver.
- AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for people with liver metastasis.
- Acceptable renal function: a. Creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation).
- Acceptable hematologic functioning (without hematologic support):
- ANC ≥ 1000 cells μL.
- Platelet count ≥ 75,000/μL.
- Hemoglobin ≥ 9.0 g/dL.
- All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female people must agree to use effective means of contraception (for example, surgical sterilization or the use of...
- Normal CSF flow and distribution by an accepted CSF flow study (e.g., 111Indium-DTPA or acceptable substitute) before first treatment with the study drug, based on study imaging interpretation and clinical correlation.
- Corticosteroids are permitted as clinically indicated.
- The subject has not recovered to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational...
- Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
- Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
- Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria).
- Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
- Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except:
- Prior radiation dose to the spinal cord and/or cauda equina is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy...
- Prior stereotactic radiosurgery (SRS) to the brain or partial brain radiotherapy is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to brainstem and/or optic structures (optic nerves, optic chiasm)...
- Prior or concurrent therapy: a. Intrathecally delivered therapy: i. Concurrent: Concurrent intrathecal therapy. ii. Prior: Intrathecal therapy given less than 14 days before study registration. b. Systemically delivered...
- Projected survival of less than 60 days.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.