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

 

GlioblastomaRecruiting Patients

Leptomeningeal
Metastases:
U.S. Phase 1 Clinical Trial

 

GlioblastomaRecruiting Patients

Leptomeningeal
Metastases:
U.S. Phase
1 Clinical
Trial

 

GlioblastomaRecruiting 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. 

View Trial on ClinicalTrials.gov

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

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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 Friendly, PDF & Email

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

5 + 2 =

News

 

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

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

Plus Therapeutics Presents Preliminary Safety and Feasibility Data from ReSPECT-LM Clinical Trial at the European Association of Nuclear Medicine Congress

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

Plus Therapeutics Presents Positive Data from Ongoing ReSPECT™ Clinical Trials at the Annual Conference on CNS Clinical Trials and Brain Metastases

June 22, 2022

Plus Therapeutics and Biocept Announce Comprehensive Laboratory Services Agreement for the ReSPECT-LM Trial

June 16, 2022

Plus Therapeutics Completes Enrollment in Cohort 1 of ReSPECT-LM Phase 1/2a Clinical Trial

March 22, 2022

Plus Therapeutics Announces First Patient Dosed in Phase 1/2a Dose Escalation Trial of 186RNL Radiotherapeutic for Leptomeningeal Metastases

November 9, 2021

Plus Therapeutics Receives FDA Fast Track Designation for 186RNL Targeted Radiotherapeutic for Leptomeningeal Metastases

October 19, 2021

Plus Therapeutics Announces FDA Clearance of Investigational New Drug Application for 186RNL for the Treatment of Leptomeningeal Metastases

August 19, 2021

Plus Therapeutics Presents Data from Preclinical Study of Rhenium-186 Nanoliposome in Leptomeningeal Metastases and Plans for Further Evaluation with Upcoming Phase 1 Clinical Trial

August 11, 2021

Plus Therapeutics to Present Data from Two Studies Supporting the Treatment of Leptomeningeal Metastases with Rhenium-186 Nanoliposome