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

Breast Cancer Clinical Trial

Official title:

A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433407
• Other study ID #: CDR0000449959
• Secondary ID: UCLA-0505075-01
• Status: Completed
• Phase: N/A
• First received: February 8, 2007
• Last updated: October 3, 2012
• Start date: August 2005

Study information

• Verified date: October 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• trastuzumab

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-cell activation in blood samples		3 months	No