This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.
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 who have already received a prior treatment of 186RNL. The clinical study treatment consists of a single administered dose of 186RNL per participant. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi. An estimated number of participants to be enrolled in the study is approximately 40. The clinical study treatment will be administered, following CED placement, by the clinical study physician. Post-treatment evaluations will be done at Days 3, 7, 14, 28, and every subsequent 28-day interval thereafter until disease progression is confirmed and all treatment related toxicities are resolved. The minimum assessment period for toxicities is 12 weeks. The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States
RECRUITINGAssessment of safety and tolerability of a second dose of 186RNL by CED as part of standard of care >30 days following first dose.
Safety and tolerability assessed by number of participants with treatment-related toxicities and/or adverse events as assessed by CTCAE v4.0 with 4-week evaluation periods for toxicity and disease assessment until disease progression is suspected.
Time frame: > 30 days
Overall Survival
To assess overall survival following 186RNL in patients with bevacizumab naïve recurrent glioblastoma following treatment with a second administration of 186RNL.
Time frame: 6 Months
Dose Distribution
To assess the dose distribution of a second dose of 186RNL by CED.
Time frame: 3 days
Overall Response Rate
To determine the overall response rate by Radiographic Assessment in Neuro-Oncology (RANO) criteria following 186RNL treatment.
Time frame: 90 days
Progression-free survival
To determine disease specific progression-free survival after 186RNL treatment.
Time frame: 6 Months
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