Trial Information
The purpose of the ReSPECT-GBM Clinical Trial is to assess the safety, tolerability, and distribution of a new medication, rhenium (186Re) obisbemeda, in adults with recurrent glioblastoma after standard surgical, radiation, and/or chemotherapy treatment. ReSPECT-GBM is supported by the U.S. National Institutes of Health / National Cancer Institute.
NATIONAL TRIAL REFERENCE NUMBER
NCT01906385
When speaking with your physician, please have the national trial reference number available.
Phase 1 Patients Treated to Date
28
Phase 2 Patients Treated to Date
9
Single Group
- All patients who enroll in the trial will receive medication while on the study.
- All patients will receive a single treatment of rhenium (186Re) obisbemeda.
Phase 1/2
- 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.
- Phase 2: If a new medication is found to be reasonably safe in a Phase 1 study, it can then be evaluated in a Phase 2 study to determine if it works. Doctors will assess whether the new medication provides a specific benefit or response, such as tumor shrinkage, improved quality of life, or longer patient survival.
Progress
- Actual Study Start: June 3, 2015
- Estimated Primary Completion: January 2025 (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: January 2025 (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 brain cancer patients, in the U.S. NIH-supported ReSPECT-GBM Phase 2 clinical trial.
Watch now to learn more.
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. Healthy volunteers are not needed.
Condition
Recurrent Glioblastoma
Age Range
Adults, 18 Years and Older
Gender
All
Imaging
Able to undergo a MRI scan
Prior Medication
Have not taken Avastin (bevacizumab)
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.
Toral Patel, M.D.
UT Southwestern Medical Center
Peter O’Donnell Jr. Brain Institute
SPECIALTIES: NEUROLOGICAL SURGERY, SKULL BASE TUMORS, NEUROLOGICAL DISORDERS
Toral Patel, M.D., is an Assistant Professor in UT Southwestern Medical Center’s nationally ranked Department of Neurological Surgery, where she specializes in brain tumor surgery.
Dr. Patel received her undergraduate degree in biomedical engineering from Johns Hopkins University and earned her medical degree at UT Southwestern Medical School. She completed an internship in general surgery at Yale-New Haven Hospital, followed by a residency in neurological surgery, serving as Chief Resident. She then received advanced training in neurosurgical oncology through a fellowship at Memorial Sloan Kettering Cancer Center before returning to UT Southwestern as a faculty member in 2014.
Dr. Patel’s research has garnered numerous awards, including the William F. Collins Resident Research Award, a Seed Grant from the American Medical Association, the UT Southwestern Medical Student Summer Research Award, the Louis E. Goodman Award, and the Johns Hopkins University Department of Biomedical Engineering Undergraduate Research Award. She currently holds a patent titled “Highly penetrative nanocarriers for treatment of CNS disease” for her research into how nanoparticles can be used to carry drugs directly to the site of brain tumors.
Dr. Patel is a member of the Society for Neuro-Oncology, the American Medical Association, the American College of Surgeons, the Congress of Neurological Surgeons, and the American Association of Neurological Surgeons.
She was included in D Magazine‘s Best Doctors list for 2018.
Jeffrey Weinberg, M.D.
UT MD Anderson Cancer Center
Anne C. Brooks Brain & Spine Center
SPECIALTIES: PRIMARY AND METASTATIC BRAIN TUMORS, SPINAL CORD TUMORS, STEREOTACTIC RADIOSURGERY
Dr. Jeffrey Weinberg is currently a Professor of Neurosurgery, Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery at The University of Texas MD Anderson Cancer Center in Houston, Texas. He is also the Director of the Intraoperative MRI Program.
Dr. Weinberg is a leader in the field of the Neurosurgical Oncology with particular knowledge about intraoperative MRI and technical expertise in surgical management of primary and metastatic brain tumors, spinal cord tumors and stereotactic radiosurgery. He has received various honors which include Excellence in Research Mentorship from the University of Texas Center for Biomedical Engineering, Houston, TX; the Excellence in Teaching Award from the University of Texas Center for Biomedical Engineering for three consecutive years, Top Doctor’s Designation by Castle Connolly and US News and World Report and most recently the MD Anderson Physician Referral Service Sam Hassenbusch Leadership and Institutional Service Award.
Dr. Weinberg is the Chair of the Peri-operative Value Analysis Team; President of the Intraoperative Imaging Society; past President of the Texas Association of Neurological Surgeons; Website Chair for the Joint Tumor Section of the AANS and CNS.
He has published more than 100 manuscripts in peer-reviewed journals and has authored 8 book chapters.
Trial Locations
There are currently 3 clinical trial locations in the United States that are actively screening and enrolling patients.
Please visit this website regularly for updates as new locations are added.
UT Health
San Antonio, Texas
UT Southwestern
Dallas, Texas
MD Anderson
Houston, Texas
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 NCT01906385 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
San Antonio, Texas
Epp Goodwin
210-450-5798
goodwine@uthscsa.edu
Morgan Seekatz
210-450-1133
ctcreferral@uthscsa.edu
UT Southwestern
Dallas, Texas
Tiffany Thomas
214-648-7094
tiffany.thomas@UTSouthwestern.edu
Omar Raslan
214-648-6691
omar.raslan@UTSouthwestern.edu
Contact Us
News
July 27, 2023
Plus Therapeutics to Present at the 2023 SNO/ASCO CNS Cancer Conference
- Presentations titled: [LMAP-21] Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial; [TIPS-23] Safety and Feasibility Results from a Phase 1/2 Clinical Trial of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma: The ReSPECT-GBM Trial; [TIPS-22] A two-part, Phase 1 study of Rhenium (186Re) Obisbemeda (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG)
July 13, 2023
Plus Therapeutics to Present at the 2nd Annual Targeted Radiopharmaceuticals Summit
- Presentations titled: Re-186 Radiolabelled NanoLiposomes for Rare Brain & Spinal Cord Tumors, and Novel Approaches to Central Nervous System Targeted Radiotherapeutics
June 29, 2023
- 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 reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois.
January 18, 2023
- 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
- 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
August 13, 2022
June 13, 2022
November 18, 2021
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
Publications
Abstracts
Posters
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.
Presentations
ReSPECT-GBM Clinical Trial Update, SNMMI 2023 Annual Meeting, June 26, 2023
Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1/2a Trial, EANM Congress, October 19, 2022
Resources
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
- VirtualTrials.com
- Voices Against Brain Cancer