CLR 131 Combined With Radiation for Head and Neck Cancer

Summary

This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants who are amenable to retreatment with radiation therapy. Participants who also have distant metastatic disease may be enrolled on this clinical trial, but they must have evaluable disease that will be clinically treated with radiation therapy, as per standard of care. All participants will receive a dosimetry test dose of CLR 131 to establish drug uptake by the tumor and enable Monte Carlo dose estimation based on CLR 131 SPECT/CT imaging evaluation. Participants showing uptake will receive a cumulative tumor dose of 60-70 Gy using personalized dose calculation (via Monte Carlo methods) of CLR 131 combined with external beam radiation.

Timeline

Start

2019-12-20

Primary completion

2022-09-19

Completion

2024-02-01

Publications

• Bruce JY, Burr A, Kimple RJ, Adam DP, Yu M, Piaskowski SM, Glazer TA, Hill P, Hartig GK, McCulloch TM, Wieland AM, Trask D, Oliver K, Longcor J, Rogus-Pulia N, Cho SY, Bednarz B, Harari PM. Safety and toxicity of Iopofosine I 131 (CLR 131) with external beam radiation therapy in recurrent or metastatic head and neck cancer: results of a phase 1 single-centre, open-label, single-arm, dose escalation and dose expansion study. EBioMedicine. 2025 Jan;111:105496. doi: 10.1016/j.ebiom.2024.105496. Epub 2024 Dec 12.

Drugs

Indications