PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||January 2003|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055705
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan Kettering Cancer Center|