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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Breast Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific; Lung Cancer; Ovarian Cancer; Prostate Cancer

Treatments: Biological: trastuzumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00433407

UCLA-0505075-01

CDR0000449959

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

trastuzumab

Experimental group

Description:

blood sample collected on different days from patients receiving trastuzumab

Treatment:

Biological: trastuzumab