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

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00636090
First received: March 9, 2008
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Metastatic Hormone Refractory Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: pre-treatment, day 19, and monthly blood samples ] [ Designated as safety issue: No ]
  • To identify expression profiles associated with AKT activation and RAD001 treatment effect. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]
  • To identify candidate plasma markers of glycolysis that reflect tumor AKT activity. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

This study involves the retention of tissue sample from tumor biopsies as well as blood samples.


Enrollment: 35
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult men enrolled in the study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636090

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Department of Defense
Investigators
Principal Investigator: Daniel J George, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636090     History of Changes
Other Study ID Numbers: DUMC-0346 Pro00000346, CA123175, R01-A2-022207
Study First Received: March 9, 2008
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013