Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027911
Status:
TERMINATED
Last Update Posted:
2013-02-15
First Post:
2001-12-07
Brief Title:
Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1LAGE Antigen Expressing Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Departure of PI
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 Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood Combining vaccine therapy with sargramostim may be effective in treating soft tissue sarcoma
PURPOSE Phase I trial to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have stage II stage III or stage IV soft tissue sarcoma
PURPOSE Phase I trial to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have stage II stage III or stage IV soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim GM-CSF in patients with stage II III or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen
Determine the immunologic profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity in patients treated with this regimen
Determine tumor responses in patients treated with this regimen
OUTLINE Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a total of 6 vaccinations Patients also receive sargramostim GM-CSF subcutaneously once daily beginning 2 days before every vaccination and continuing for 5 days Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 12 months
Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim GM-CSF in patients with stage II III or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen
Determine the immunologic profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity in patients treated with this regimen
Determine tumor responses in patients treated with this regimen
OUTLINE Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a total of 6 vaccinations Patients also receive sargramostim GM-CSF subcutaneously once daily beginning 2 days before every vaccination and continuing for 5 days Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 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-G01-2035 | None | None | None |
| CPMC-IRB-13578 | None | None | None |
| LUDWIG-LUD00-024 | None | None | None |