Latest News: Positive Data from Ongoing ReSPECT-LM Clinical Trial Presented at Society for Neuro-Oncology Annual Meeting
Leptomeningeal Metastases:
U.S. Phase 1 Clinical Trial
Recruiting Patients
Leptomeningeal
Metastases:
U.S. Phase 1 Clinical Trial
Recruiting Patients
Leptomeningeal
Metastases:
U.S. Phase
1 Clinical
Trial
Recruiting Patients
Trial Information
Leptomeningeal metastases (LM) are a rare but typically fatal complication of advanced cancer in which cancer cells (typically from the breast or lung) spread to the central nervous system (CNS) and are found in either the leptomeninges (membrane surrounding the brain and spinal cord) or cerebrospinal fluid (CSF) (circulates nutrients and chemicals to the brain and spinal cord). Despite affecting over 110,000 people annually in the U.S., highly effective, approved treatments for LM are not available.
Plus Therapeutics is developing Rhenium (186Re) Obisbemeda, an innovative, targeted radiotherapeutic for rare and difficult-to-treat cancers. In the U.S. multi-center ReSPECT-LM Phase 1 clinical trial, Rhenium (186Re) Obisbemeda will be administered through an intraventricular catheter (Ommaya reservoir) in patients with LM. The treatment consists of a single administered dose of Rhenium (186Re) Obisbemeda per patient on an outpatient basis by the clinical trial physician.
NATIONAL TRIAL REFERENCE NUMBER
NCT05034497
When speaking with your physician, please have the national trial reference number available.
Patients Treated to Date
Single Group
- All patients who enroll in the trial will receive medication while on the study.
- All patients will receive a single dose of Rhenium (186Re) Obisbemeda.
Phase 1
- A Phase 1 study of a new medication is usually the first that involves human volunteers who have the disease or condition the investigational medicine is designed to treat. The primary objective of Phase 1 studies is to identify the highest dose of the new medication that can be safely given without serious side effects.
Progress
- Actual Study Start: December 6, 2021
- Estimated Primary Completion: July 30, 2023 (the date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected)
- Estimated Study Completion: December 30, 2023 (the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events, that is, the last participant’s last visit).
Patient Eligibility
Only a qualified healthcare professional can determine whether or not you are eligible to participate in a clinical trial. However, this information may be beneficial in initiating a conversation with your physician. Patient reimbursement of up to $599 for time and travel is available.
Age Range
Adults, 18 years and older
Informed Consent
Able to understand the study purposes and risks
Condition
Leptomeningeal Metastases
Gender
All; Women have negative pregnancy test at screening; Subjects must use effective contraception during study
Additional eligibility criteria may be found on ClinicalTrials.gov
Principal Investigators
There is a physician who is responsible for the scientific and technical direction of the clinical trial at each location.
Andrew Brenner, M.D., Ph.D.
UT Health San Antonio, Mays Cancer Center
SPECIALTIES: MEDICAL ONCOLOGY, INTERNAL MEDICINE
A specialist in both breast cancer and malignancies of the brain and spinal cord, Andrew Brenner, M.D., Ph.D., not only focuses on clinical management, but also on the development of novel therapies to treat breast cancers and central nervous system tumors.
A graduate of Texas A&M University, he earned his bachelor’s degree in biochemistry and went on to earn his doctorate in biological science and tumor biology at The University of Texas M.D. Anderson Cancer Center – Science Park. His doctoral thesis focused on the role of the cyclin dependent kinase inhibitor p16INK4a in mammary tumorigenesis and immortilization. Dr. Brenner’s current interests have transitioned from cell cycle to the effect of hypoxia on chemokines and escape from antiangiogenics and the role of obesity in promoting breast tumorigenesis.
Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency in internal medicine at Scott and White Hospital in Lubbock. He completed his fellowship in hematology and medical oncology at the UT Health San Antonio.
Michael Youssef, M.D.
UT Southwestern Medical Center
SPECIALTIES: NEURO-ONCOLOGY
Michael Youssef, M.D., is an Assistant Professor in the Department of Neurology and the Department of Hematology and Oncology at UT Southwestern Medical Center. He specializes in neuro-oncology.
Dr. Youssef earned his medical degree at the Medical University of South Carolina. He completed a residency in neurology at Baylor College of Medicine and then received advanced training in neuro-oncology through a fellowship at the University of Texas MD Anderson Cancer Center.
Certified by the American Board of Psychiatry and Neurology, he joined the UT Southwestern faculty in 2020.
Dr. Youssef’s clinical and research interests include glioblastoma; primary brain tumors; rare brain tumors, including ependymoma and medulloblastoma; neurologic complications of systemic cancer therapy; brain metastasis; and leptomeningeal disease.
He is a member of the American Academy of Neurology, the American Brain Tumor Association, the Society for Neuro-Oncology, and the American Society for Clinical Oncology.
Trial Locations
Please visit this website regularly for updates as new locations are added.
UT Health Science Center
San Antonio
UT Southwestern Medical Center
Dallas
What Can You Do Next?
Participating in a clinical trial is an important decision. If you believe this clinical trial might be a good fit and are interested in participating, please take the next step to see if you are eligible.
Discuss With Your Physician
Anyone participating in a clinical trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your physician first.
Print, save, or email this page to your physician to discuss at your next visit.
Be sure to have National Trial Reference Number NCT05034497 available.
Contact A Trial Coordinator
A trial coordinator is a specialized researcher who supports the management and coordination of clinical research studies. If you are interested in participating in a clinical trial, you may call a trial coordinator directly at one of the trial locations below.
UT Health Science Center
San Antonio
Epp Goodwin
210-450-5798
goodwine@uthscsa.edu
UT Southwestern Medical Center
Dallas
Omar Raglan
214-648-6691
omar.raslan@UTSouthwestern.edu
Request Information
News
November 19, 2022
The Company’s oral presentation titled, “Preclinical Data and Initial Clinical Experience in the Phase 1/2a Dose Escalation Trial of Rhenium-186 Nanoliposome (186RNL) in Leptomeningeal Metastases [LM]: the ReSPECT-LM Trial [CTNI-02]”, highlighted data from the first 2 cohorts which demonstrates the potential of rhenium (186Re) obisbemeda to treat LM.
October 19, 2022
ReSPECT-LM Phase 1 clinical trial selected as TOP Trials Oral Presentation; Treatment was well tolerated without dose limiting toxicities and all patients showed a decrease in spinal fluid tumor cell counts; ReSPECT-GBM Phase 1 clinical data selected as Top-Rated Oral Presentation and inclusion in opening Highlights Lecture
October 5, 2022
Plus Therapeutics Announces Patient Webinar in Recognition of Breast Cancer Awareness Month
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that Dr. Andrew Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-LM clinical trial, is scheduled to conduct a live patient-focused webinar entitled, “A Promising New Targeted Radiation Therapy for Leptomeningeal Metastases in Breast Cancer, Lung Cancer, and Other Malignancies: An Introduction” on Sunday, October 9, 2022 at 7:00 PM Eastern.
August 17, 2022
Plus Therapeutics Awarded $17.6 Million from State of Texas for ReSPECT-LM Clinical Trial
Funding from the Cancer Prevention and Research Institute of Texas (CPRIT), the second largest global public funder of cancer research, will support the majority of the development costs of 186RNL for leptomeningeal metastases.
August 13, 2022
June 22, 2022
June 16, 2022
Plus Therapeutics Completes Enrollment in Cohort 1 of ReSPECT-LM Phase 1/2a Clinical Trial
March 22, 2022
November 9, 2021
October 19, 2021
August 19, 2021
August 11, 2021
Publications
Presentations
Posters
Resources
Note: all external links
- African American Breast Cancer Alliance
- American Brain Tumor Association
- American Cancer Society
- Brain Tumor Network
- Cancer Prevention & Research Institute of Texas
- Dictionary of Cancer Terms
- End Brain Cancer Initiative
- LUNGevity Foundation
- MedlinePlus (NIH)
- METAvivor
- National Brain Tumor Society
- National Breast Cancer Coalition
- National Cancer Institute
- National Comprehensive Cancer Network
- Support Groups Listing
- The Brain Tumour Charity
- Trial Connect
- VirtualTrials.com
- Voices Against Brain Cancer