Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004032
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
1999-12-10
Brief Title:
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intraperitoneal IP Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-hB71 Plus IP rIFN-gamma for Patients With Ovarian Cancer A Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer Vaccines made from a persons cancer cells may make the body build an immune response to and kill their tumor cells Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer
Detailed Description:
OBJECTIVES
I Determine whether intraperitoneal IP injections of epithelial ovarian carcinoma cells infected with ALVAC-hB71 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer
OUTLINE This is a dose-escalation study of ALVAC-hB71 infected tumor cells
Patients receive ALVAC-hB71 infected tumor cells intraperitoneally IP on days 4 11 and 18 Patients also receive interferon gamma IP on days 8 10 15 and 17 In the absence of disease progression up to 6 courses of therapy may be given If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine interferon gamma may be given alone Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB71 infected tumor cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months until disease progression
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
I Determine whether intraperitoneal IP injections of epithelial ovarian carcinoma cells infected with ALVAC-hB71 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer
OUTLINE This is a dose-escalation study of ALVAC-hB71 infected tumor cells
Patients receive ALVAC-hB71 infected tumor cells intraperitoneally IP on days 4 11 and 18 Patients also receive interferon gamma IP on days 8 10 15 and 17 In the absence of disease progression up to 6 courses of therapy may be given If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine interferon gamma may be given alone Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB71 infected tumor cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months until disease progression
PROJECTED ACCRUAL A total of 12 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 |
|---|---|---|---|
| CDR0000065850 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |
| MDA-ID-96253 | None | None | None |
| U01CA062461 | NIH | None | None |