CLR 131 Combined With Radiation for Head and Neck Cancer
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
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 24 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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborators:
Cellectar Biosciences, Inc. National Institute of Dental and Craniofacial Research (NIDCR)