T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00433407
First received: February 8, 2007
Last updated: October 3, 2012
Last verified: October 2012

February 8, 2007
October 3, 2012
August 2005
February 2006   (final data collection date for primary outcome measure)
T-cell activation in blood samples [ Time Frame: 3 months ] [ Designated as safety issue: No ]
T-cell activation in blood samples
Complete list of historical versions of study NCT00433407 on ClinicalTrials.gov Archive Site
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T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors
A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment

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 and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Prostate Cancer
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Biological: trastuzumab
Experimental: trastuzumab
blood sample collected on different days from patients receiving trastuzumab
Intervention: Biological: trastuzumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
February 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00433407
CDR0000449959, UCLA-0505075-01
No
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Mark D. Pegram, MD Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP