Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091273
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2004-09-07
Brief Title:
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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 Vaccines made from peptides may make the body build an immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer
PURPOSE This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides tetanus toxoid helper peptide and sargramostim GM-CSF emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer
OUTLINE This is an open-label study
Patients receive vaccine comprising ovarian cancer synthetic peptides tetanus toxoid helper peptide sargramostim GM-CSF and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1 8 and 15 On day 22 patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine Patients then receive additional vaccine as above only to the primary vaccination site on days 29 36 and 43
After completion of study treatment patients are followed at 1 week 1 month every 3 months for 9 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 9 patients will be accrued for this study
Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides tetanus toxoid helper peptide and sargramostim GM-CSF emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer
OUTLINE This is an open-label study
Patients receive vaccine comprising ovarian cancer synthetic peptides tetanus toxoid helper peptide sargramostim GM-CSF and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1 8 and 15 On day 22 patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine Patients then receive additional vaccine as above only to the primary vaccination site on days 29 36 and 43
After completion of study treatment patients are followed at 1 week 1 month every 3 months for 9 months every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 9 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 |
|---|---|---|---|
| UVACC-33204 | None | None | None |
| UVACC-OVA3 | None | None | None |