Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069940
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2003-10-03
Brief Title:
Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
Status:
COMPLETED
Status Verified Date:
2010-12
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 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 cause a stronger immune response and kill more tumor cells
PURPOSE This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor
PURPOSE This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor
Detailed Description:
OBJECTIVES
Determine the feasibility of treatment with telomerase 540-548 peptide vaccine and sargramostim GM-CSF in patients with sarcoma or brain tumor
Determine the safety and tolerability of this regimen in these patients
Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients
Determine preliminarily the clinical response if any of patients treated with this regimen
OUTLINE Patients receive telomerase 540-548 peptide vaccine subcutaneously SC on day 3 and sargramostim GM-CSF SC on days 1-4 of weeks 1 3 5 7 9 11 15 19 and 23
PROJECTED ACCRUAL A total of 35 patients 20 adult and 15 pediatric will be accrued for this study
Determine the feasibility of treatment with telomerase 540-548 peptide vaccine and sargramostim GM-CSF in patients with sarcoma or brain tumor
Determine the safety and tolerability of this regimen in these patients
Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients
Determine preliminarily the clinical response if any of patients treated with this regimen
OUTLINE Patients receive telomerase 540-548 peptide vaccine subcutaneously SC on day 3 and sargramostim GM-CSF SC on days 1-4 of weeks 1 3 5 7 9 11 15 19 and 23
PROJECTED ACCRUAL A total of 35 patients 20 adult and 15 pediatric 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 |
|---|---|---|---|
| P30CA006516 | NIH | None | httpsreporternihgovquickSearchP30CA006516 |