Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433407
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2007-02-08
Brief Title:
T-Cell Response in Patients Receiving Trastuzumab andor Chemotherapy for HER2-Positive Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
Status:
COMPLETED
Status Verified Date:
2012-10
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:
RATIONALE Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment It may also help the study of cancer in the future
PURPOSE This laboratory study is looking at blood samples from patients receiving trastuzumab andor chemotherapy for HER2-positive solid tumors to assess T-cell response
PURPOSE This laboratory study is looking at blood samples from patients receiving trastuzumab andor chemotherapy for HER2-positive solid tumors to assess T-cell response
Detailed Description:
OBJECTIVES
Assess T-cell activation in blood samples of patients receiving trastuzumab Herceptin andor chemotherapy for HER2-positive solid tumors
OUTLINE Blood samples are collected from patients at baseline and on days 21 42 and 84 of trastuzumab Herceptinchemotherapy Patients may be contacted 3-6 months after completion of trastuzumabchemotherapy to donate another blood specimen
Blood samples are examined for T-cell proliferation and intracellular cytokine production CD8 T-cell response HER2neu-specific antibody titers and skin hypersensitivity test responses are also measured
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Assess T-cell activation in blood samples of patients receiving trastuzumab Herceptin andor chemotherapy for HER2-positive solid tumors
OUTLINE Blood samples are collected from patients at baseline and on days 21 42 and 84 of trastuzumab Herceptinchemotherapy Patients may be contacted 3-6 months after completion of trastuzumabchemotherapy to donate another blood specimen
Blood samples are examined for T-cell proliferation and intracellular cytokine production CD8 T-cell response HER2neu-specific antibody titers and skin hypersensitivity test responses are also measured
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| UCLA-0505075-01 | None | None | None |