Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002780
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Women With Metastatic Breast Cancer
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER PHASE III
Status:
UNKNOWN
Status Verified Date:
2001-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the toxicities of the combination of low dose interleukin-2 IL-2 sargramostim GM-CSF and multiple doses of activated T cells ATC following peripheral blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the breast II Evaluate the efficacy of this regimen in these patients
OUTLINE Patients receive filgrastim G-CSF subcutaneously daily for 5 days prior to peripheral blood stem cell PBSC collection or for 2 days prior to bone marrow harvest Following PBSC collection or bone marrow harvest patients receive high dose chemotherapy consisting of cyclophosphamide IV carboplatin IV and thiotepa IV over days -6 through -3 Patients undergo PBSC transplantation on day 0 Following PBSC transplantation patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65 continuous low dose interleukin-2 IL-2 IV over days 1-65 and sargramostim GM-CSF subcutaneously on days 5-21 Patients are followed at day 100 as clinically indicated and then annually
PROJECTED ACCRUAL Approximately 40-60 patients will be accrued for this study within 1-2 years
OUTLINE Patients receive filgrastim G-CSF subcutaneously daily for 5 days prior to peripheral blood stem cell PBSC collection or for 2 days prior to bone marrow harvest Following PBSC collection or bone marrow harvest patients receive high dose chemotherapy consisting of cyclophosphamide IV carboplatin IV and thiotepa IV over days -6 through -3 Patients undergo PBSC transplantation on day 0 Following PBSC transplantation patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65 continuous low dose interleukin-2 IL-2 IV over days 1-65 and sargramostim GM-CSF subcutaneously on days 5-21 Patients are followed at day 100 as clinically indicated and then annually
PROJECTED ACCRUAL Approximately 40-60 patients will be accrued for this study within 1-2 years
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-V96-0902 | None | None | None |
| STLMC-BRM-9503 | None | None | None |