The Cancer World

Molecular Profiling Protocol (SCRI-CA-001)

Rick Dunetz

February 11, 2008

This study is currently recruiting participants. Verified by Scottsdale Healthcare, September 2007
Sponsors and Collaborators: Scottsdale Healthcare Translational Genomics Research Institute (TGen)
Information provided by: Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT00530192

Purpose

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.

Condition Intervention

Refractory Cancer

Other: Treatment based on Molecular Profiling

Genetics Home Reference related topics: Cancer

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type: Interventional

Study Design: Other, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Scottsdale Healthcare:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.
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.

Estimated Enrollment: 92

Study Start Date: September 2006

Eligibility Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Criteria

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: