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

NCT ID: NCT00433407

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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trastuzumab

blood sample collected on different days from patients receiving trastuzumab

Group Type EXPERIMENTAL

trastuzumab

Intervention Type BIOLOGICAL

Interventions

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trastuzumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D. Pegram, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

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Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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UCLA-0505075-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000449959

Identifier Type: -

Identifier Source: org_study_id