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

Refractory Cancer

Intervention / Treatment

Other: Treatment based on Molecular Profiling

Study Type

Interventional

Enrollment (Actual)

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

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