NCT04252248

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Anogenital Cancer

Interventions

Type	Name	Description
DRUG	Dacogen	Intravenous (i.v.) infusion of 20 mg/m2 over 1 hour repeated daily for 5 days starting on day 1. Single repetition of cycle on day 29.

Timeline

• Start date: 2019-10-11
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2020-02-05
• Last updated: 2021-10-06

Locations

1 site across 1 country: Germany