Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055705
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2003-03-06
Brief Title:
PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 dosePatients 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
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 dosePatients 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-1617 | None | None | None |
| MSKCC-02080 | None | None | None |