A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
I. Determine the maximum tolerated dose (MTD) of PV701 administered by direct intratumoral
injection in patients with advanced or recurrent unresectable squamous cell carcinoma of the
head and neck.
II. Determine the toxicity of intratumoral PV701 in these patients. III. Determine response
rate and time to progression at the injection site in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive intratumoral PV701 once weekly
for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PV701 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, at least 6 evaluable patients are treated at that dose.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 6-10
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) of PV701 based on the incidence of dose-limiting toxicity (DLT) as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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