Overview

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

Status:
Terminated

Trial end date:
2021-06-15

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

University Hospital Heidelberg

Collaborators:

Janssen-Cilag G.m.b.H
National Center for Tumor Diseases, Heidelberg

Treatments:

Decitabine