News: Plus Therapeutics Announces FDA Clearance of Investigational New Drug Application for 186RNL for the Treatment of Leptomeningeal Metastases
U.S. Phase 1 Clinical Trial
U.S. Phase 1 Clinical Trial
Leptomeningeal metastases (LM) are a rare but typically fatal complication of advanced cancer in which cancer cells 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 are not available.
Plus Therapeutics is developing 186RNL (Rhenium-186 NanoLiposome), an innovative, targeted radiotherapeutic for multiple rare and difficult-to-treat cancers. In the U.S. multi-center ReSPECT-LM Phase 1 clinical trial, 186RNL will be administered through an intraventricular catheter (Ommaya reservoir) in patients with LM. The treatment consists of a single administered dose of 186RNL per patient on an outpatient basis by the clinical trial physician. The ReSPECT-LM U.S. Phase 1 Clinical Trial is planned to begin in late 2021.
NATIONAL TRIAL REFERENCE NUMBER
When speaking with your physician, please have the national trial reference number available.
Patients Treated to Date
- All patients who enroll in the trial will receive medication while on the study.
- All patients will receive a single dose of Rhenium-186 NanoLiposome (186RNL).
- 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.
- Actual Study Start: late 2021
- Estimated Primary Completion: to be determined (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: to be determined (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).
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.
Adults, 18 years and older
Able to understand the study purposes and risks
All; Women have negative pregnancy test at screening; Subjects must use effective contraception during study
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
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.
Please visit this website regularly for updates as new locations are added.
UT Health Science Center
UT Southwestern Medical Center
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.
November 9, 2021
October 19, 2021
August 19, 2021
August 11, 2021
Note: all external links
- American Brain Tumor Association
- American Cancer Society
- Brain Tumor Network
- Dictionary of Cancer Terms
- End Brain Cancer Initiative
- MedlinePlus (NIH)
- National Brain Tumor Society
- National Cancer Institute
- National Comprehensive Cancer Network
- Support Groups Listing
- The Brain Tumour Charity
- Trial Connect
- Voices Against Brain Cancer