A phase I study to study arsenic trioxide with radiation and hyperthermia in advanced head and neck cancer.

OBJECTIVE

Arsenic trioxide [ATO] is a pluripotent drug with potentials to have pro-oxidant, angiogenesis inhibitor, flow inhibitor and radiation sensitizer properties.

METHODS

The present study is a Phase I trial to assess the safety of ATO in advanced or recurrent head and neck cancer treated with radiation and hyperthermia. Patients received ATO at 10, 20 and 30 mg per week a day prior to hyperthermia.

RESULTS

It was assumed that vascular collapse would be complete by 24 h. Administration of ATO at 20 mg was safe with no toxicity due to ATO. No amplification of toxicities due to radiation or hyperthermia was evident. Patients without prior treatment showed better response. A total of 11 patients were included in this Phase I study.

CONCLUSIONS

Patients who received 30 mg of ATO weekly showed non-serious acute toxicities. No further escalation of dose was attempted.