Molecular Profiling Protocol (SCRI-CA-001)

July 9, 2009 updated by: Scottsdale Healthcare

A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

This is an open-label, multicenter pilot study in patients with advanced solid tumors.

The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Oncology Specialties
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
      • Scottsdale, Arizona, United States, 85258
        • Tgen Clinical Research Services
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Oncology
      • Los Angeles, California, United States, 90048
        • Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Central Indiana Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Center Of The Carolinas
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology Hematology
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
  • Be defined as refractory to the last line of therapy
  • Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

Exclusion Criteria:

  • Patients with symptomatic CNS metastasis
  • Any previous history of another malignancy within 5 years of study entry
  • Uncontrolled intercurrent illness
  • Known HIV, HBV, HCV infection
  • Pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.
Time Frame: Every 8 weeks disease assessments are performed
Every 8 weeks disease assessments are performed

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.
Time Frame: Time of Profiling- Baseline
Time of Profiling- Baseline
To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scottsdale Healthcare

Collaborators

Translational Genomics Research Institute

Investigators

  • Principal Investigator: Daniel D Von Hoff, MD, TGen Clinical Research Services at Scottsdale Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion

March 1, 2009

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCRI-CA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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