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
29
Phase 2 Patients Treated to Date
19
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
Toral Patel, M.D.
UT Southwestern Medical Center
Peter O’Donnell Jr. Brain Institute
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
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.
Contact Us
Request More Information
News
Plus Therapeutics and SpectronRx Announce Radiotherapeutic Manufacturing Partnership
October 1, 2024
September 18, 2024
July 2, 2024
June 7, 2024
Plus Therapeutics Expands Management Team and Reports $3.3M Advance Payment from CPRIT
April 22, 2024
April 9, 2024
Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management Team
December 12, 2023
November 29, 2023
Plus Therapeutics to Present at the 5th Targeted Radiopharmaceuticals Summit Europe
- Presentation titled “Re-186 Radiolabelled NanoLiposomes for Rare Brain and Spinal Cord Tumors”
November 20, 2023
- Median overall survival (mOS) in 15 patients with recurrent glioblastoma (rGBM) from the Phase 2 study is 13 months, which is 63% better than current standard of care (bevacizumab monotherapy) of 8 months; 9 of the 15 patients remain alive
- Median progression free survival (mPFS) is 11 months, compared to SOC at 4 months
- Rhenium (186Re) Obisbemeda continues to demonstrate a favorable safety profile, despite delivering up to 20x the dose of radiation (up to 740 Gy) typically delivered by external beam radiation therapy (EBRT) for rGBM patients (up to 35 Gy)
- Imaging data presented by Andrew Brenner, MD, PhD is consistent with the efficacy signal of Rhenium (186Re) Obisbemeda in rGBM
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
Treatment of Recurrent Glioblastoma via Convection Enhanced Delivery with Rhenium (186Re) Obisbemeda: ReSPECT-GBM Phase 1/2 Trial Update, Congress of Neurological Surgeons Annual Meeting 2024, September 30, 2024
Targeted Radiolabeled Nanoliposomes for Rare CNS Cancers: An Update on the ReSPECT Phase 1/2 Trials, Gordon Research Conference, July 8, 2024
KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference, SNO Annual Meeting 2023, November 20, 2023.
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
Updates
SpectronRx Partnership
BREAKING NEWS: Plus Therapeutics and SpectronRx Announce Radiotherapeutic Manufacturing Partnership Partnership will expand Plus’ capability to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda and reinforce supply chain redundancy Press...
ABTA 5K NYC
Come join us at the upcoming @the_abta 5K run in New York City! It’s not too late to register as we join together in the fight against brain cancer. Plus Therapeutics is proud to be a sponsor and will have a booth on-site to provide education about our clinical...
CNS 2024
Reminder to come by Plus Therapeutics at the @CNS_update 2024 Annual Meeting at Booth #2038 Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the...
#WorldCancerResearchDay
Today is #WorldCancerResearchDay! Join us in celebrating the incredible advancements in cancer research and the dedicated researchers working tirelessly to find new treatments and cures. Every breakthrough brings us one step closer to a cancer-free future🔬🌟🎗️ Learn...