NCT00433407

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

February 8, 2007

Last Update Submit

October 3, 2012

Conditions

Breast CancerLung CancerOvarian CancerProstate CancerSarcomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancermale breast cancerrecurrent breast cancerstage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent small cell lung cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcoma

Outcome Measures

Primary Outcomes (1)

  • T-cell activation in blood samples

    3 months

Study Arms (1)

trastuzumab

EXPERIMENTAL

blood sample collected on different days from patients receiving trastuzumab

Biological: trastuzumab

Interventions

trastuzumabBIOLOGICAL
trastuzumab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsOvarian NeoplasmsProstatic NeoplasmsSarcomaBreast Neoplasms, MaleCarcinoma, Ovarian EpithelialCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mark D. Pegram, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

August 1, 2005

Primary Completion

February 1, 2006

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

US(1)