Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumours of the oropharynx: a phase 1 study.

Completed

Conditions: head and neck carcinoma - HPV-positive oropharyngeal carcinoma in the expansion cohort.
10072990

Registration Number: NL-OMON33865

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

·UICC TNM I-IV, for which curable (high dosing) radiotherapy is advised.
·Histological proven HPV-positive oropharyngeal carcinoma in the dose escaltion schedule.
·WHO performance status 0-4
·Less then 10% weight loss the last 6 months
·Normal serum bilirubin
·Normal white blood cells, neutrophils, platelets, hemoglobin
·No prior history of head or neck radiotherapy
·No uncontrolled infectious disease
·Willing and able to comply with the study prescriptions
·Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria

·Patients receiving agents with nephrotoxic potential. Such agents must be discontinued at least seven days prior to starting therapy with cidofovir.
·Hypersensitivity to cidofovir
·History of clinically severe hypersensitivity to probenecid or other sulfa-containing medications.
·History of kidney function disorder.
·Serum creatinine concentration >132,6 micromol/L, a calculated creatinine clearance /= 100mg/dL (equivalent to >/= 2+ proteinuria).
·Recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
·Pregnant women.
·Age under 18 years.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective<br /><br>·To define the maximum tolerated dose (MTD) of cidofovir in combination with<br /><br>standard dose of radiotherapy in Human Papilloma Virus-positive head and neck<br /><br>carcinomas.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives<br /><br>·To explore p53-related gene activity in patients before and during treatment<br /><br>with Cidofovir.<br /><br>·To evaluate PET/CT findings oropharyngeal carcinomas before and after<br /><br>cidofovir administration. </p><br>