A Phase I Clinical Trial To Assess The Safety And Efficacy Of Intraperitoneal PV701 Administrations In Patients With Advanced Or Recurrent Malignancy Largely Confined To The Peritoneal Cavity
- Determine the dose-limiting toxicity and maximum tolerated dose of intraperitoneal
PV701 after desensitization in patients with advanced or recurrent malignancy largely
confined to the peritoneal cavity these patients.
- Determine the optimal desensitization dose of intravenous PV701 in these patients.
- Determine the safety of this drug, in terms of cumulative toxicity, in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Determine the presence and duration of viral shedding, viremia, and immunogenicity of
OUTLINE: This is an open-label, dose-escalation study comprising 2 different treatment
- Schedule I (optimal desensitization dose): Patients receive PV701 IV over 30 minutes on
day 1 followed by intraperitoneal (IP) PV701 on days 4, 7, and 9. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PV701 IV and IP until the optimal
desensitization dose (ODD) is determined. The ODD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose-limiting toxicity (DLT).
- Schedule II (maximum tolerated dose):Patients receive the same regimen as in schedule I
using PV701 IV at the ODD.
Cohorts of 3-6 patients receive escalating doses of PV701 IP until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience DLT.
PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 10-17
Masking: Open Label, Primary Purpose: Treatment
David R. Spriggs, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|