Finding studies
Finding studies
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Lead
Memorial Sloan Kettering Cancer Center
With
OBJECTIVES: * 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 this drug. OUTLINE: This is an open-label, dose-escalation study comprising 2 different treatment schedules. * 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 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
