Leptomeningeal Metastases (LM), sometimes referred to as leptomeningeal disease, neoplastic meningitis, or meningeal carcinomatosis, is a rare but serious condition that happens when cancer cells spread to the membranes surrounding the brain and spinal cord. LM is most commonly found in patients with melanoma, breast, lung, or gastrointestinal cancer. Unfortunately, there are no FDA approved treatments specifically for LM.
Plus Therapeutics is developing a new targeted radiation therapy, Rhenium (186Re) Obisbemeda, for central nervous system cancers such as LM. In the U.S. ReSPECT-LM clinical trial, doctors will give LM patients a single dose of Rhenium (186Re) Obisbemeda through a small catheter placed under the patient’s scalp. This drug will be administered in less than 5 minutes in a hospital setting and the patient will go home the same day.
The ReSPECT-LM clinical trial is funded, in part, by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas, the second largest public funding source for cancer research in the world.
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 (186Re) Obisbemeda.
- A Phase 1 study is the first step in testing a new treatment in humans. A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment. It may also test how the treatment affects the body. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Phase I clinical trials usually include only a small number of patients who have not been helped by other treatments.
- 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).
Plus Therapeutics is evaluating rhenium (186Re) obisbemeda, a novel radiotherapy for patients with Leptomeningeal Metastases in a Phase 1 clinical trial.
Watch now to learn more.
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
Leptomeningeal Metastases from any solid tumor cancers (i.e. breast, lung, melanoma, gastrointestinal)
Able to understand the study purposes and risks
All; Women have negative pregnancy test at screening; Subjects must use effective contraception during study
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
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.
Priya Kumthekar, M.D.
Northwestern Memorial Hospital
SPECIALTIES: NEUROLOGY and NEURO-ONCOLOGY
Dr. Priya Kumthekar is an Associate Professor of Neurology and Hematology/Oncology, and the Director of the Cancer Trials Office at the Robert H Lurie Comprehensive Cancer Center at Northwestern University. Kumthekar is board certified in neurology and neuro-oncology and has an MD from Northeastern Ohio Universities College of Medicine.
Dr. Kumthekar completed her residency training in neurology at Northwestern University/McGaw and her Neuro-Oncology UCNS Accredited Clinical Fellowship at the same institution.
Dr. Kumthekar is involved in many committees and councils at the university and hospital, including the Neuro-Oncology Fellowship Director and the Internal Advisory Committee for the Quantitative Data Sciences Core. Additionally, she is an Executive Officer of the Alliance for Clinical Trials in Neuro-Oncology, which oversees all Neuro-oncology clinical trials for the Alliance for Clinical Trials, a member of the National Clinical Trial Network. Dr. Kumthekar is the recipient of several teaching awards and is a member of numerous professional societies and organizations.
Please visit this website regularly for updates as new locations are added.
UT Health Science Center
UT Southwestern Medical Center
Northwestern Memorial Hospital
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.
February 1, 2023
Plus Therapeutics Completes Enrollment in Second ReSPECT-LM Phase 1 Trial Cohort of Rhenium (¹⁸⁶Re) Obisbemeda for the Treatment of Leptomeningeal Metastases
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced completion of enrollment in Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM).
January 18, 2023
Plus Therapeutics Announces First Patient Dosed in ReSPECT-GBM Phase 2b Trial of Rhenium (186Re) Obisbemeda for Treatment of Recurrent Glioblastoma
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the first patient has been dosed in the ReSPECT-GBM Phase 2b dose expansion clinical trial evaluating rhenium (186Re) obisbemeda for the treatment of recurrent glioblastoma (GBM).
November 19, 2022
Plus Therapeutics Provides Updates on ReSPECT™ Clinical Trials at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology
ReSPECT-GBM clinical trial of rhenium (186Re) obisbemeda in recurrent glioblastoma continues to demonstrate safety and overall survival correlates with radiation dose to tumor. ReSPECT-GBM Phase 2 trial enrollment has begun.
September 12, 2022
Plus Therapeutics Presents Positive Phase 1 Data from ReSPECT-GBM Clinical Trial at the European Society for Medical Oncology Congress 2022
August 13, 2022
Plus Therapeutics Presents Positive Data from Ongoing ReSPECT™ Clinical Trials at the Annual Conference on CNS Clinical Trials and Brain Metastases
June 13, 2022
Plus Therapeutics Reports Positive Clinical Outcomes from ReSPECT-GBM Trial at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting
November 18, 2021
Plus Therapeutics Announces Positive Interim Data from ReSPECT™-GBM Phase 1 Clinical Trial at the 2021 Society for Neuro-Oncology Annual Meeting
August 21, 2021
Plus Therapeutics Announces Presentation of Data from the ReSPECT™-GBM Trial and Plans for Treating Pediatric Brain Cancer
July 22, 2021
Plus Successfully Treats First Patient in Latest Dosing Cohort in ReSPECT™-GBM Trial
June 16, 2021
Plus Therapeutics Announces DSMB Approval to Proceed into Eighth Cohort in ReSPECT™ Glioblastoma Trial
December 15, 2020
Plus Therapeutics Completes Sixth Dosing Cohort in ReSPECT™ Glioblastoma Trial
December 1, 2020
Plus Therapeutics Expands ReSPECT™ Clinical Trial to MD Anderson Cancer Center
November 19, 2020
Plus Therapeutics Announces Positive Interim Data from ReSPECT™ Phase 1 Clinical Trial in Recurrent Glioblastoma
November 13, 2020
Plus Therapeutics Announces Webinar to Present ReSPECT™ Glioblastoma Clinical Trial Update
October 29, 2020
Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT™ Glioblastoma Trial
October 2, 2020
Plus Therapeutics Announces Brain Cancer Clinical Advisory Team
October 1, 2020
ReSPECT Glioblastoma Clinical Trial Data to be Presented at 2020 Society for Neuro-Oncology Annual Meeting
September 15, 2020
Plus Therapeutics Receives Fast Track Designation From FDA for Its Novel Glioblastoma Treatment
September 1, 2020
Plus Therapeutics, Inc. receives FDA Orphan Drug Designation for its Novel Glioblastoma Treatment
July 28, 2020
Plus Therapeutics Completes Fifth Dose Escalation Cohort of the ReSPECT™ Glioblastoma Clinical Trial and Expands Trial Sites
May 12, 2020
Plus Therapeutics Announces Patient-Focused Presentation Supporting Brain Tumor Awareness Month
Brenner, Andrew et al. “Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: The ReSPECT Phase 1 Trial.” Neuro-Oncology, Volume 23, Issue Supplement_6, November 2021, Pages vi65-vi66.
Brenner, Andrew et al. “High Absorbed Doses of Rhenium-186 NanoLiposomes (RNL) in Recurrent GBM: A Phase 1 Study.” Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Page ii186.
Brenner, Andrew et al. “Safety & Feasibility of Rhenium-186 Nanoliposomes (186RNL) in Recurrent Glioma: the ReSPECT Phase 1 Trial.” 2022 Annual Conference on CNS Clinical Trials & Brain Metastases.
Floyd, John et al. “Image-Guided Rhenium-186 NanoLiposome (186RNL) Brachytherapy in the Treatment of Recurrent Glioblastoma: Technique, Image Analysis, Dosimetry, and Monitoring.” 2021 ASTRO Annual Meeting.
Brenner, Andrew et al. “Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT Phase 1 Trial.” E-Poster, 2021 American Society of Clinical Oncology Annual Meeting, June 4-8, 2021.
Brenner, Andrew et al. “Safety and Feasibility of Rhenium-186 NanoLiposomes (RNL) in Recurrent GBM: the ReSPECT Phase 1 Trial.” E-Poster, 2020 Society for Neuro-Oncology Annual Meeting, November 19-21, 2020.
Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1/2a Trial, EANM Congress, October 19, 2022
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