T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors
This study has been completed.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00433407
First received: February 8, 2007
Last updated: October 3, 2012
Last verified: October 2012
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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 |
Biological: trastuzumab |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Soft Tissue Sarcoma
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- T-cell activation in blood samples [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: trastuzumab
blood sample collected on different days from patients receiving trastuzumab
|
Biological: trastuzumab |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433407
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Study Chair: | Mark D. Pegram, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00433407 History of Changes |
| Other Study ID Numbers: | CDR0000449959, UCLA-0505075-01 |
| Study First Received: | February 8, 2007 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Ovarian Neoplasms Prostatic Neoplasms Neoplasms Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013