RECRUITING

Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

Conditions

Leptomeningeal Metastasis Neoplastic Processes Neoplasms Neoplasms Pathologic Processes Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Neoplasm Metastasis Meningeal Carcinomatosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A 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

Quick Facts

Study Start:2025-07-02

Study Completion:2031-10-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07098806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 18 years of age. 2. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB. 3. Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C). 4. Karnofsky performance status of 70 to 100. 5. Acceptable liver function: 1. Bilirubin ≤ 1.5 times the upper limit of normal. 2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver. 3. AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis. 6. Acceptable renal function: 7. Acceptable hematologic functioning (without hematologic support): 1. ANC ≥ 1000 cells μL. 2. Platelet count ≥ 75,000/μL. 3. Hemoglobin ≥ 9.0 g/dL. 8. 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. 9. 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. 10. Corticosteroids are permitted as clinically indicated.	1. 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 drugs, or other medications that were administered prior to study, at time of study registration. 2. Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.) 3. Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt. 4. Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria). 5. Serious intercurrent illnesses, which could interfere with the planned treatment schedule. 6. Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except: 1. 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 has been \> 14 days and ≤ 6 months, or was ≤45 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been \> 6 months. 2. 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) using α/β ratio of 3 and if prior radiotherapy has been \> 14 days and ≤ 6 months, or was ≤ 45 Gy to the brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been \> 6 months. 7. Prior or concurrent therapy: 8. Projected survival of less than 60 days.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years of age.
2. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
3. Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).
4. Karnofsky performance status of 70 to 100.
5. Acceptable liver function:
1. Bilirubin ≤ 1.5 times the upper limit of normal.
2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver.
3. AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis.
6. Acceptable renal function:
7. Acceptable hematologic functioning (without hematologic support):
1. ANC ≥ 1000 cells μL.
2. Platelet count ≥ 75,000/μL.
3. Hemoglobin ≥ 9.0 g/dL.
8. 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.
9. 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.
10. Corticosteroids are permitted as clinically indicated.

1. 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 drugs, or other medications that were administered prior to study, at time of study registration.
2. Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
3. Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
4. Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria).
5. Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
6. Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except:
1. 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 has been \> 14 days and ≤ 6 months, or was ≤45 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been \> 6 months.
2. 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) using α/β ratio of 3 and if prior radiotherapy has been \> 14 days and ≤ 6 months, or was ≤ 45 Gy to the brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been \> 6 months.
7. Prior or concurrent therapy:
8. Projected survival of less than 60 days.

Contacts and Locations

Study Contact

Rachael Hershey

CONTACT

1(210)791-8723

patients@respect-trials.com

Andrew Brenner, M.D.,Ph.D

CONTACT

1(210)791-8723

patients@respect-trials.com

Study Locations (Sites)

The Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Plus Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-02

Study Completion Date2031-10-02

Study Record Updates

Study Start Date2025-07-02

Study Completion Date2031-10-02

Terms related to this study

Keywords Provided by Researchers

Neoplastic Processes Neoplasms
Neoplasms
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasm Metastasis
Meningeal Carcinomatosis

Additional Relevant MeSH Terms

Leptomeningeal Metastasis