A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
N/A
N/A
Both
Breast Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
OBJECTIVES:
- Assess T-cell activation in blood samples of patients receiving trastuzumab
(Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of
trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion
of trastuzumab/chemotherapy to donate another blood specimen.
Blood samples are examined for T-cell proliferation and intracellular cytokine production.
CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test
responses are also measured.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of solid epithelial tumor, including, but not limited to, the following:
- Breast cancer
- Ovarian cancer
- Lung cancer
- Uterine cancer
- Prostate cancer
- HER2/neu-positive disease by immunohistochemistry or fluorescent in situ
hybridization
- Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel,
docetaxel, fluorouracil, or estramustine)
PATIENT CHARACTERISTICS:
- Absolute neutrophil count > 1,000/mm^3
- Absolute lymphocyte count > 400/mm^3
- Platelet count > 90,000/mm^3
- Hemoglobin > 8 g/dL
PRIOR CONCURRENT THERAPY:
- No other chemotherapy within the past 4 weeks
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
T-cell activation in blood samples
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Mark D. Pegram, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000449959
NCT ID:
NCT00433407
Start Date:
August 2005
Completion Date:
Related Keywords:
- Breast Cancer
- Lung Cancer
- Ovarian Cancer
- Prostate Cancer
- Sarcoma
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- male breast cancer
- recurrent breast cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- limited stage small cell lung cancer
- recurrent small cell lung cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage I uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- Breast Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
- Prostatic Neoplasms
- Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
