Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage

Summary

Open-label, single-center phase I study to evaluate first signs of efficacy and to confirm the safety and tolerability of a decitabine safe-dose treatment in two strata of patients with HPV induced anogenital and head and neck cancers (Stratum 1: patients with high rist for disease recurrence; Stratum 2: patients with failure of standard therapy). The study is expected to enroll 18 patients overall (9 patients in each stratum). The duration of the trial for each patient is expected to be 6 months (two 28 day cycles of study treatment plus four months of additional follow-up). The overall duration of the trial is expected to be approximately 42 months.

Timeline

Start

2019-10-11

Primary completion

2021-06-15

Completion

2021-06-15

Outcome

Outcome not reported

Stopped: “Organizational reasons”

Drugs

Indications