National Cancer Institute (NCI)
This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of camonsertib with concurrent head and neck stereotactic body radiotherapy (SBRT) reirradiation for patients with recurrent head and neck squamous cell carcinoma (HNSCC). II. To determine the recommended phase 2 dose (RP2D) of camonsertib in combination with concurrent SBRT in these patients. SECONDARY OBJECTIVES: I. To assess overall response rate within the radiation therapy field for patients treated with camonsertib and SBRT. II. To assess progression-free survival (PFS) with camonsertib and SBRT in patients with recurren…
Inclusion Criteria: * Patients must have histologically confirmed recurrent or metachronous (second primary) unresectable head and neck squamous cell carcinoma involving the oral cavity, oropharynx, larynx, hypopharynx, and/or paranasal sinus, or cervical lymphadenopathy with unknown primary. Core needle biopsy (preferably at least three 18-gauge cores) or incisional biopsy is preferred over fine needle aspiration (FNA) for diagnosis of recurrent disease or new primary head and neck squamous cell carcinoma to provide sufficient tumor tissue for correlative studies. Unresectable refers both to…
Undergo collection of blood samples
Given PO
Undergo CT or PET/CT
Undergo PET/CT
Undergo SBRT