CLR 131 Combined With Radiation for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT04105543|
Recruitment Status : Suspended (due to COVID-19)
First Posted : September 26, 2019
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: CLR 131||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single center, dose escalation and dose expansion study|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Combination of CLR 131 With External Beam Radiation in Head and Neck Cancer|
|Actual Study Start Date :||December 20, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: CLR 131 Dose Escalation
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m^2 Dose Level 1 (beginning dose) = 15.6 mCi/m^2 Dose Level 2 (escalation dose) = 18.75 mCi/m^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
Drug: CLR 131
CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
Other Name: I-131-CLR1404
- Incidence of Adverse Events [ Time Frame: up to 18 weeks ]Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- CLR 131 Tumor Uptake via SPECT/CT Imaging [ Time Frame: Up to 8 days ]Investigators will use SPECT/CT imaging scans to predict the adsorbed dose of CLR 131 to tumors with the Monte Carlo method.
- Median Radiation Treatment Time [ Time Frame: up to 14 weeks ]
- Median Number of Dose Delays Due to Toxicity [ Time Frame: up to 14 weeks ]
- Overall Response Rate (ORR) [ Time Frame: up to 9 months ]ORR defined as the proportion of subjects who experience either a partial response or complete response within 6 months post completion of EBRT as measured by standard of care imaging (e.g. CT, MR, PET-MR).
- Change in Swallow Function: DIGEST Scale [ Time Frame: up to 9 months ]Swallow function assessed by Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale before and after treatment. The DIGEST scale cross references a clinician determined 'safety' grade with an 'efficiency' grade for an overall score between 0-4 where 0 is asymptomatic and 4 is life threatening.
- Change in Quality of Life: MDADI Score [ Time Frame: up to 15 months ]Quality of life assessed by MD Anderson Dysphagia Inventory score (MDADI) before and after treatment. MDADI is a 36-item self-assessment with global, emotional, functional, and physical sub-scales. Total possible composite score range is 20-100 where 20 is extremely low functioning and 100 is high functioning.
- Change in Stimulated Salivary Flow [ Time Frame: up to 9 months ]Change in Stimulated Salivary Flow before and after treatment (mL/min).
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): NCT04105543
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Justine Bruce, MD||University of Wisconsin, Madison|