Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006228
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2000-09-11
Brief Title:
Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Anti-HER-2 Monoclonal Antibody Trastuzumab Herceptin in Combination With Low Dose Interleukin-2 Proleukin in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Interleukin-2 may stimulate a persons white blood cells to kill breast cancer cells Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the response rate and toxicity to low-dose IL-2 with intermediate-pulse dose interleukin 2 IL-2 and trastuzumab in patients with uni-dimensional measurable metastatic breast cancer and human epidermal growth factor receptor 2 HER2 positive 3 overexpression by immunohistochemistry IHC method or positive by fluorescent in situ hybridization FISH who either have had evidence of progressive disease while receiving a trastuzumab-containing regimen or have had progressive disease within 12 months of receiving a trastuzumab-containing regimen
SECONDARY OBJECTIVES
I To perform correlative immunologic assays to determine the degree of natural killer NK cell expansion in response to low-dose IL-2 and the effectiveness of patients peripheral blood mononuclear cells PBMC in a standard antibody-dependent cell-mediated cytotoxicity ADCC assay directed against a HER2 target cell
II To determine the pharmacokinetics of trastuzumab using an every 2-week schedule
III To determine Fc-gamma receptor polymorphisms from study patients
OUTLINE This is a multicenter study
Patients receive trastuzumab intravenously IV over 30-90 minutes on days 1 and 8 and aldesleukin subcutaneously SC on days 2-7 and 9-21 Beginning on day 22 patients receive trastuzumab IV over 30 minutes every 14 days Patients also receive aldesleukin SC daily on days 1-14 Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 30 days
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study
I To estimate the response rate and toxicity to low-dose IL-2 with intermediate-pulse dose interleukin 2 IL-2 and trastuzumab in patients with uni-dimensional measurable metastatic breast cancer and human epidermal growth factor receptor 2 HER2 positive 3 overexpression by immunohistochemistry IHC method or positive by fluorescent in situ hybridization FISH who either have had evidence of progressive disease while receiving a trastuzumab-containing regimen or have had progressive disease within 12 months of receiving a trastuzumab-containing regimen
SECONDARY OBJECTIVES
I To perform correlative immunologic assays to determine the degree of natural killer NK cell expansion in response to low-dose IL-2 and the effectiveness of patients peripheral blood mononuclear cells PBMC in a standard antibody-dependent cell-mediated cytotoxicity ADCC assay directed against a HER2 target cell
II To determine the pharmacokinetics of trastuzumab using an every 2-week schedule
III To determine Fc-gamma receptor polymorphisms from study patients
OUTLINE This is a multicenter study
Patients receive trastuzumab intravenously IV over 30-90 minutes on days 1 and 8 and aldesleukin subcutaneously SC on days 2-7 and 9-21 Beginning on day 22 patients receive trastuzumab IV over 30 minutes every 14 days Patients also receive aldesleukin SC daily on days 1-14 Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 30 days
PROJECTED ACCRUAL A total of 17-37 patients 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-2012-01402 | REGISTRY | None | None |
| CDR0000068150 | None | None | None |
| OSU-99H0192 | None | None | None |
| OSU-9945 | None | None | None |
| NCI-195 | None | None | None |
| 9945 | OTHER | None | None |
| 195 | OTHER | None | None |
| N01CM17102 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17102 |