Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01906385|
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : July 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: Rhenium Liposome Treatment||Phase 1 Phase 2|
This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through a convection enhanced delivery catheter (CED catheter) in participants with recurrent Glioma (GBM).
The clinical study treatment consists of a single administered dose of 186RNL per participant.
The clinical study will include the evaluation of multiple separate dose levels (dose escalation). Three to six participants may be treated at each dose.
The maximum number of participants to be enrolled in the study is approximately 55.
The clinical study treatment will be administered, following CED placement, by the clinical study physician.
Participants will be followed for up to 12 months after the clinical study drug is administered.
The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dual Phase 1/2 Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)|
|Actual Study Start Date :||June 3, 2015|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Experimental: Rhenium Liposome Treatment
Arm Experimental: Dose Escalation for Cohorts 1-8 Each participant will receive a single administration of 186RNL. At each dose level, a minimum of three to a maximum of six participants will be enrolled.
If no dose limiting toxicity is observed in the initial three participants, then the then the next higher dose level cohort will open for enrollment.
The dose escalation scheme will follow a modified Fibonacci dose escalation scheme as shown below:
COHORT ACTIVITY Cohort 1 (1.0 mCi) Cohort 2 (2.0 mCi) Cohort 3 (4.0 mCi) Cohort 4 (8.0 mCi) Cohort 5 (13.4 mCi) Cohort 6 (22.3 mCi) Cohort 7 (31.2 mCi) Cohort 8 (41.5 mCi)
Drug: 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 CED 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.
Other Name: Rhenium-186 NanoLiposome
- 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 radioactive 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: Erika Butler, MSemail@example.com|
|Contact: Norman LaFrance, MD (CMO)||firstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Omar Raslan 214-648-6691 Omar.Raslan@UTSouthwestern.edu|
|Principal Investigator: Toral Patel, MD|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Summer Stovall 713-745-4243 email@example.com|
|Principal Investigator: Jeffrey Weinberg, MD|
|The Cancer Therapy and Research Center at UTHSCSA||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Epp Goodwin 210-450-5798|
|Principal Investigator: Andrew J Brenner, M.D., Ph.D.|
|Sub-Investigator: John R Floyd, M.D.|
|Sub-Investigator: William T Phillips, M.D.|
|Study Chair:||Marc Hedrick, MD||Plus Therapeutics, President and CEO|