Clinical trial NCT00433407: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors
Official title: A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-12
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and/or 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®) 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.

Eligibility 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

Primary outcomes:
measure: T-cell activation in blood samples
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Mark D. Pegram, MD
role: STUDY_CHAIR
References: