Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004216
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2000-01-28
Brief Title:
VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of a Live Genetically Modified Salmonella Typhimurium VNP20009 for the Treatment of Cancer by Intratumoral Injection
Status:
COMPLETED
Status Verified Date:
2007-12
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 Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and safety of intratumoral live genetically modified Salmonella typhimurium VNP20009 in patients with refractory superficial solid tumors II Determine the efficacy of VNP20009 in these patients
OUTLINE This is a dose-escalation study Patients receive intratumorally injected live genetically modified Salmonella typhimurium VNP20009 on day 0 The tumor is biopsied on day 14 Cohorts of 3-6 patients receive escalating doses of VNP20009 until the maximum tolerated dose MTD or the optimal biologic dose OBD is determined The MTD is defined as the highest dose in which no more than 1 patient in a cohort of 6 experiences dose-limiting toxicity DLT The OBD is defined as the dose at which 3-6 patients of a cohort have greater than 10 million colony-forming units of VNP20009 per gram in the tumor biopsy Prior to reaching the OBD 2 to 3 additional patients may be entered at a previous dose level shown to be safe to undergo biopsy of the injected lesion between days 5 and 8 Patients are assessed for systemic tumor response 4-5 weeks after treatment If the injected lesion is stable or responding and non-injected lesions have not grown patients may receive up to 2 additional courses of treatment Patients receive one of the following antibiotic regimens upon evidence of progressive disease DLT or discontinuation from the study First line Ciprofloxacin IV or orally every 12 hours on day 1 then orally twice a day for 18 days Second line Ceftriaxone IV on day 1 then cefixime orally for 16 days Third line Co-trimoxazole orally twice a day for 21 days Patients are followed for an additional 4 weeks after initiation of antibiotic therapy
PROJECTED ACCRUAL A total of 12-40 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive intratumorally injected live genetically modified Salmonella typhimurium VNP20009 on day 0 The tumor is biopsied on day 14 Cohorts of 3-6 patients receive escalating doses of VNP20009 until the maximum tolerated dose MTD or the optimal biologic dose OBD is determined The MTD is defined as the highest dose in which no more than 1 patient in a cohort of 6 experiences dose-limiting toxicity DLT The OBD is defined as the dose at which 3-6 patients of a cohort have greater than 10 million colony-forming units of VNP20009 per gram in the tumor biopsy Prior to reaching the OBD 2 to 3 additional patients may be entered at a previous dose level shown to be safe to undergo biopsy of the injected lesion between days 5 and 8 Patients are assessed for systemic tumor response 4-5 weeks after treatment If the injected lesion is stable or responding and non-injected lesions have not grown patients may receive up to 2 additional courses of treatment Patients receive one of the following antibiotic regimens upon evidence of progressive disease DLT or discontinuation from the study First line Ciprofloxacin IV or orally every 12 hours on day 1 then orally twice a day for 18 days Second line Ceftriaxone IV on day 1 then cefixime orally for 16 days Third line Co-trimoxazole orally twice a day for 21 days Patients are followed for an additional 4 weeks after initiation of antibiotic therapy
PROJECTED ACCRUAL A total of 12-40 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067446 | REGISTRY | None | None |
| NCI-V99-1581 | Registry Identifier | PDQ Physician Data Query | None |