Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081211
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2004-04-07
Brief Title:
Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of intratumoral in the tumor PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma cancer of the head and neck Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells
Detailed Description:
OBJECTIVES
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 months
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 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000360664 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| 12157B | None | None | None |
| N01CM17102 | NIH | None | None |