Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01536054
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2011-12-30
Brief Title:
Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cavity Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Clinical Trial of mTOR Inhibition With Sirolimus for Enhancing ALVAC2-NY-ESO-1MTRICOM Vaccine Induced Anti-Tumor Immunity in Ovarian Fallopian Tube and Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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:
This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial fallopian tube or primary peritoneal cavity cancer Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety of ALVAC2-NY-ESO-1 MTRICOM vaccine with sirolimus at varying dose and schedule
SECONDARY OBJECTIVES
I To determine the effectiveness of sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity peripheral blood NY-ESO-1 specific cluster of differentiation CD8 and CD4 T-cells peripheral blood NY-ESO-1 specific antibodies peripheral blood frequency of CD4CD25forkhead box P3 FOXP3 regulatory T-cells
II Explore time to disease progression
OUTLINE This is a dose-escalation study of sirolimus
Patients receive ALVAC2-NY-ESO-1 MTRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 Patients also receive sirolimus orally PO once daily QD on days 1-14 OR 15-28 OR 1-28 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive an additional course of ALVAC2-NY-ESO-1 MTRICOM vaccine only followed by ALVAC2-NY-ESO-I MTRICOM vaccine SC 8 weeks after completion of course 4
After completion of study treatment patients are followed up at 30 days and 6 and 12 months
I Determine the safety of ALVAC2-NY-ESO-1 MTRICOM vaccine with sirolimus at varying dose and schedule
SECONDARY OBJECTIVES
I To determine the effectiveness of sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity peripheral blood NY-ESO-1 specific cluster of differentiation CD8 and CD4 T-cells peripheral blood NY-ESO-1 specific antibodies peripheral blood frequency of CD4CD25forkhead box P3 FOXP3 regulatory T-cells
II Explore time to disease progression
OUTLINE This is a dose-escalation study of sirolimus
Patients receive ALVAC2-NY-ESO-1 MTRICOM vaccine subcutaneously SC on day 1 and sargramostim GM-CSF SC on days 1-4 Patients also receive sirolimus orally PO once daily QD on days 1-14 OR 15-28 OR 1-28 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive an additional course of ALVAC2-NY-ESO-1 MTRICOM vaccine only followed by ALVAC2-NY-ESO-I MTRICOM vaccine SC 8 weeks after completion of course 4
After completion of study treatment patients are followed up at 30 days and 6 and 12 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 |
|---|---|---|---|
| NCI-2011-02964 | REGISTRY | CTRP Clinical Trial Reporting Program | None |