Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066729
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2003-08-06
Brief Title:
Vaccine Therapy in Treating Patients With Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ISA-51 In Patients With Ovarian Primary Peritoneal Or Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2023-10
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 may make the body build an immune response to kill tumor cells
PURPOSE A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial primary peritoneal or fallopian tube cancer
PURPOSE A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial primary peritoneal or fallopian tube cancer
Detailed Description:
OBJECTIVES
Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial primary peritoneal or fallopian tube cancer
Determine the immunologic profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity induced by this regimen in these patients
OUTLINE This is an open-label study
Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1 4 7 10 and 13 in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks week 16 and then every 6-12 weeks for 2 years or until disease progression
Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial primary peritoneal or fallopian tube cancer
Determine the immunologic profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity induced by this regimen in these patients
OUTLINE This is an open-label study
Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1 4 7 10 and 13 in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks week 16 and then every 6-12 weeks for 2 years or until disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| LUD2002-014 | OTHER | Ludwig Institute for Cancer Research | None |
| MSKCC-03034 | OTHER | None | None |