Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01906385|
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Astrocytoma||Radiation: Rhenium Liposome Treatment||Phase 1 Phase 2|
Rhenium-186 (186Re) (half-life 90 hours) is a reactor produced isotope with great potential for medical therapy. It is in the same chemical family as Technetium-99m (99mTc), a radioactive tracer that is the most commonly used isotope for diagnostic scintigraphic imaging in nuclear medicine. Like 99mTc, rhenium is not taken up by bone and is readily cleared by the kidneys. 186Re emits both therapeutic beta particles and every 10 isotope decays is associated with a gamma photon. The average 186Re beta particle path length in tissue of 2mm is ideal for treatment of solid tumors. Additionally, the emitted gamma photons have similar photon energy to those emitted by 99mTc, therefore allowing for imaging of the isotope within the body on standard nuclear imaging machines available in routine medical practice. Therefore, the 186Re isotope has great potential in CED applications of local therapy of solid tumors. However, a carrier is needed to deliver the isotope to the brain and maintain its localization at the desired site, as otherwise it would quickly disperse and be carried away from the site of injection by the circulatory system.
Liposomes are spontaneously forming lipid nanoparticles that have been well studied for over 30 years. Although larger liposomes can be manufactured, the most useful size range for drug carrier applications is 80-100 nm. Liposomes of this size are often referred to as nanoliposomes and have the ability to facilitate retention at the site of injection. A method for the efficient loading of liposomes with the to very high levels of specific activity has been developed. These rhenium-labeled nanoliposomes (186RNL) have shown great promise in preclinical studies 186RNL of glioblastoma that surpassed results typically seen with currently standard treatment modalities such as oral temozolomide or intravenous bevacizumab.
This is a single center, sequential cohort, open-label, dose-escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioblastoma|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: Rhenium Liposome Treatment||
Radiation: Rhenium Liposome Treatment
At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.
- Maximum Tolerated Dose [ Time Frame: 90 days ]Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.
- Dose Distribution [ Time Frame: 3 days ]SPECT imaging of the radioacitve materials spread across the tumor and surrounding brain
- Response rate [ Time Frame: 90 days ]Evaluation of overall response rate by RANO criteria
- Survival [ Time Frame: 6 months ]Disease specific progression free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906385
|Contact: Epp Goodwinfirstname.lastname@example.org|
|Contact: Ofelia Romeroemail@example.com|
|United States, Texas|
|The Cancer Therapy and Research Center at UTHSCSA||Recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: Andrew J Brenner, M.D., Ph.D.|
|Sub-Investigator: John R Floyd, M.D.|
|Sub-Investigator: William T Phillips, M.D.|
|Principal Investigator:||Andrew J Brenner, MD, PhD||The University of Texas Health Science Center at San Antonio|