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Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00636090
Collaborator
United States Department of Defense (U.S. Fed)
35
Enrollment
1
Location
36
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Jan 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001. [pre-treatment, day 29, and monthly blood samples]

    Secondary Outcome Measures

    1. To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition. [pre-treatment, day 19, and monthly blood samples]

    2. To identify expression profiles associated with AKT activation and RAD001 treatment effect. [pre-treatment, day 29, and monthly blood samples]

    3. To identify candidate plasma markers of glycolysis that reflect tumor AKT activity. [pre-treatment, day 29, and monthly blood samples]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • United States Department of Defense

    Investigators

    • Principal Investigator: Daniel J George, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00636090
    Other Study ID Numbers:
    • Pro00000346
    • CA123175
    • R01-A2-022207
    First Posted:
    Mar 14, 2008
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 4, 2013