Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003184
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Women With Metastatic Breast Cancer
Sponsor:
Providence Cancer Center Earle A Chiles Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2000-11
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 made from breast cancer cells may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer
PURPOSE Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line MDA-MB-231
Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231
Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231
Observe for tumor regression
OUTLINE This is a dose-escalation study
Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim GM-CSF or with or without BCG Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months Patients may receive 1 of 2 different doses of GM-CSF GM-CSF is administered with the vaccination then every 12 hours for 7 days Monthly vaccinations may continue as long as response is shown
Cohorts of 5 patients each are treated at each dosecombination Each cohort completes treatment before the next cohort is accrued
Patients are followed at weeks 4 and 8 then every 2 months for 6 months then every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 18 months
Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line MDA-MB-231
Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231
Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231
Observe for tumor regression
OUTLINE This is a dose-escalation study
Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim GM-CSF or with or without BCG Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months Patients may receive 1 of 2 different doses of GM-CSF GM-CSF is administered with the vaccination then every 12 hours for 7 days Monthly vaccinations may continue as long as response is shown
Cohorts of 5 patients each are treated at each dosecombination Each cohort completes treatment before the next cohort is accrued
Patients are followed at weeks 4 and 8 then every 2 months for 6 months then every 3 months for 1 year and then every 6 months until disease progression
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study within 18 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-V98-1379 | None | None | None |
| PPMC-IRB-94-78 | None | None | None |
| OCC-ONC-9408-L | None | None | None |