Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005023
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2000-04-06
Brief Title:
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase I Vaccine Trial of a HER-2Neu Peptide Incorporated Into PLG Microspheres in Patients With Advanced Stage HER2-Expressing Cancers
Status:
COMPLETED
Status Verified Date:
2017-11
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 tumor cells Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer
Detailed Description:
OBJECTIVES I Determine the safety of serial intradermal or subcutaneous vaccinations of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide PLG microspheres with adjuvant sargramostim GM-CSF in patients with stage III or IV HER-2 expressing cancers II Determine whether cytotoxic T lymphocytes CTL specific for the HER-2 protein can be elicited in patients with HLA-A2 by immunization with this regimen III Determine which route of immunization intradermal or subcutaneous is more effective in generating HER-2 specific CTL in these patients on this regimen IV Determine the extent to which escalated dose of PLG peptide affects the immune response in these patients on this regimen
OUTLINE Patients undergo leukapheresis prior to study and after final vaccination Patients are sequentially entered into one of three treatment arms Arm I Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide PLG microspheres with adjuvant sargramostim GM-CSF Arm II Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF Arm III Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 15 patients 5 per treatment arm will be accrued for this study
OUTLINE Patients undergo leukapheresis prior to study and after final vaccination Patients are sequentially entered into one of three treatment arms Arm I Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide PLG microspheres with adjuvant sargramostim GM-CSF Arm II Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF Arm III Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 15 patients 5 per treatment arm 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 |
|---|---|---|---|
| NCI-V99-1574 | None | None | None |
| UWASH-103 | None | None | None |