Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027807
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2001-12-07
Brief Title:
Biological Therapy in Treating Women With Stage IV Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Treatment of Stage IV Breast Cancer With OKT3 x Herceptin Armed Activated T Cells Low Dose IL-2 And GM-CSF Phase I Only as of 4-22-09 as Per IRB Approval Date
Status:
COMPLETED
Status Verified Date:
2016-02
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining different types of biological therapies may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining different biological therapies in treating women who have stage IV breast cancer
PURPOSE Phase III trial to study the effectiveness of combining different biological therapies in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of armed activated T cells given in combination with interleukin-2 and sargramostim GM-CSF in women with stage IV breast cancer
Determine the toxicity profile of this regimen in these patients
Determine the clinical response and overall and progression-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of armed activated T cells
Patients undergo peripheral blood mononuclear cell PBMC collection The PBMCs are treated ex vivo with monoclonal antibody OKT3 to form armed activated T cells ATC The armed ATC are expanded for 14 days in interleukin-2 IL-2
Patients receive armed ATC IV over 30 minutes twice weekly for 4 weeks Patients also receive IL-2 subcutaneously SC once daily and sargramostim GM-CSF SC twice weekly beginning 3 days before the first infusion of armed ATC and continuing until 7 days after the last infusion of armed ATC
Cohorts of 3-6 patients receive escalating doses of armed ATC until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose
Patients are followed at 1 2 and 5 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for the phase I portion of this study and a total of 18-33 patients will be accrued for the phase II portion of this study within 4-6 years
PLEASE NOTE THIS STUDY WAS INTENDED TO BE A PHASE III STUDY BUT NEVER MOVED FORWARD TO PHASE II 4-22-09
Determine the maximum tolerated dose of armed activated T cells given in combination with interleukin-2 and sargramostim GM-CSF in women with stage IV breast cancer
Determine the toxicity profile of this regimen in these patients
Determine the clinical response and overall and progression-free survival of patients treated with this regimen
OUTLINE This is a dose-escalation study of armed activated T cells
Patients undergo peripheral blood mononuclear cell PBMC collection The PBMCs are treated ex vivo with monoclonal antibody OKT3 to form armed activated T cells ATC The armed ATC are expanded for 14 days in interleukin-2 IL-2
Patients receive armed ATC IV over 30 minutes twice weekly for 4 weeks Patients also receive IL-2 subcutaneously SC once daily and sargramostim GM-CSF SC twice weekly beginning 3 days before the first infusion of armed ATC and continuing until 7 days after the last infusion of armed ATC
Cohorts of 3-6 patients receive escalating doses of armed ATC until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose
Patients are followed at 1 2 and 5 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for the phase I portion of this study and a total of 18-33 patients will be accrued for the phase II portion of this study within 4-6 years
PLEASE NOTE THIS STUDY WAS INTENDED TO BE A PHASE III STUDY BUT NEVER MOVED FORWARD TO PHASE II 4-22-09
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| 2006-130 | OTHER | None | None |
| RWMC-0635146 | None | None | None |
| WSU-010307M1F | OTHER | None | None |
| WSU-0312004412 | OTHER | Wayne State University - Human Investigation Committee | httpsreporternihgovquickSearchP30CA022453 |