Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment

NCT05460507 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2021-GB-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.

Conditions

Glioma

Keywords

Glioma; Brain Tumor; Radiotherapy; Glioblastoma; Recurrent Glioblastoma; Rhenium; Rhenium Nanoliposome; Brain Cancer; GBM; High Grade Glioma; Glioblastoma Multiform; Grade IV Astrocytoma

Outcome Measures

Primary Outcomes (2)

• Assessment of safety and tolerability of a second dose of 186RNL by CED as part of standard of care >30 days following first dose.

  Safety and tolerability assessed by number of participants with treatment-related toxicities and/or adverse events as assessed by CTCAE v4.0 with 4-week evaluation periods for toxicity and disease assessment until disease progression is suspected.

  > 30 days

• Overall Survival

  To assess overall survival following 186RNL in patients with bevacizumab naïve recurrent glioblastoma following treatment with a second administration of 186RNL.

  6 Months

Secondary Outcomes (3)

• Dose Distribution

  3 days

• Overall Response Rate

  90 days

• Progression-free survival

  6 Months

Study Arms (1)

Retreatment with Rhenium Liposome

EXPERIMENTAL

Each participant will receive a single administration of 186RNL. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi.

Drug: Retreatment Rhenium Liposome

Interventions

Retreatment Rhenium Liposome DRUG

At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the CED catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.

Also known as: Rhenium-186 NanoLiposome

Retreatment with Rhenium Liposome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient must present with biopsy and histology proven glioma following initial treatment with 186RNL. The type and grade of glioma to follow the 2021 WHO Classification of Tumors of the Central Nervous System, allowing Grade III and IV gliomas.
• At least 90 days from prior dose of 186RNL at time of screening.
• Patients who receive treatment with antiepileptic medications must have a two-week history of stable dose of antiepileptic without seizures prior to dosing.
• Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms.
• A volume of enhancing tumor which falls within the treatment field volume being evaluated in the respective cohort (see 4.1 Design).
• ECOG performance status of 0 to 2; ECOG 3 acceptable if Principal Investigator and treating physician confirm in patient's interest in study/re-treatment.
• Life expectancy of at least 2 months
• Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal and AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)
• Acceptable renal function: Serum creatinine ≤1.5xULN
• Acceptable hematologic status (without hematologic support): ANC ≥1000 cells/uL, Platelet count ≥100,000/uL if no bleeding, Hemoglobin ≥7.0 g/dL. Given the absence of hematological toxicity in the ongoing recurrent glioblastoma trial (#12-02) and the need for CED catheter placement, the Investigator and Sub-investigator (neurosurgeon) placing the CED catheter may determine that it is in the patient's best interest and acceptably safe to proceed with this criteria with hematological support or, if no bleeding, Platelet count ≥75,000/uL without support, ANC 1000 cells/uL and Hemoglobin ≥7.0 g/dL
• 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.
• Patients must have malignant glioma that has progressed on or after standard treatment (surgery, radiotherapy, and/or chemotherapy) and are planned to undergo stereotactic biopsy as per standard of care.

You may not qualify if:

• The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
• The subject has contraindications to CNS Magnetic Resonance Imaging (MRI).
• The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for any prior Adverse Events (CTCAE) v4.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.
• The subject is pregnant or breast-feeding.
• The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety include:
• Uncontrolled hypertension (two or more blood pressure readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
• non-healing wound, ulcer, or bone fracture
• clinically significant cardiac arrhythmias affecting cardiac function
• untreated hypothyroidism
• uncontrolled systemic infection
• symptomatic congestive heart failure or unstable, untreated angina pectoris within 3 months prior study drug
• myocardial infarction, stroke, transient ischemic attack within 6 months
• known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix
• The subject has an inherited bleeding diathesis or coagulopathy with the risk of bleeding.
• The subject has received any of the following prior anticancer therapy:

Sponsors & Collaborators

• Plus Therapeutics: lead

Study Sites (1)

The Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Glioma; Brain Neoplasms; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma

Study Officials

• Andrew J Brenner, PhD

  The Cancer Therapy and Research Center at UTHSCSA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael Hershey

CONTACT

1(210) 791-8723; patients@respect-trials.com

Andrew Brenner, PhD

CONTACT

1(210) 791-8723; patients@respect-trials.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 15, 2022
• Study Start: December 12, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)