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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00433407 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Lung Cancer Ovarian Cancer Prostate Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: trastuzumab Procedure: chemotherapy Procedure: immunologic technique Procedure: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of solid epithelial tumor, including, but not limited to, the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Mark D. Pegram, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000449959, UCLA-0505075-01 |
| Study First Received: | February 8, 2007 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00433407 |
| Health Authority: | United States: Federal Government |
|
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 II prostate cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer stage I uterine sarcoma stage II uterine sarcoma |
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Thoracic Neoplasms Genital Neoplasms, Male Prostatic Diseases Gonadal Disorders Malignant mesenchymal tumor Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Soft tissue sarcomas Genital Diseases, Female Neoplasms, Connective and Soft Tissue Respiratory Tract Diseases Lung Neoplasms Trastuzumab Breast Diseases |
Endocrine Gland Neoplasms Ovarian cancer Non-small cell lung cancer Ovarian Neoplasms Skin Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Recurrence Carcinoma, Small Cell Breast Neoplasms, Male Lung Diseases Sarcoma Uterine sarcoma |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adnexal Diseases |
