• 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:

• 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530192

Contacts

Contact: Joyce Ingold, RN, MSN OCN
480-323-1339
[email protected]

Contact: Elizabeth Campbell, RN, OCN, CCRC
602-513-1286
[email protected]

Locations

United States, Alabama

Oncology Specialties
Recruiting

• Huntsville, Alabama, United States, 35805
• Contact: Kelly Herndon, RN, BSN, 256-705-4215 [email protected]
• Principal Investigator: Jeremy Hon, MD

United States, Arizona

TGen Clinical Research Services
Recruiting

• Scottsdale, Arizona, United States, 85258
• Principal Investigator: Daniel Von Hoff, MD

Mayo Clinic
Not yet recruiting

• Scottsdale, Arizona, United States, 85259
• Contact: Jennifer Funke, MS 480-301-6767 [email protected]
• Principal Investigator: Tom Fitch, MD

United States, California

Tower Oncology
Recruiting

• Beverly Hills, California, United States, 90211
• Contact: Wendy Batista, RN, BSN, OCN 310-205-5703 [email protected]
• Principal Investigator: Peter Rosen, MD

Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center
Recruiting

• Los Angeles, California, United States, 90048
• Contact: Tina Tolbert 310-423-0594 [email protected]
• Principal Investigator: David Agus, MD

United States, Indiana

Central Indiana Cancer Center
Recruiting

• Indianapolis, Indiana, United States, 46227
• Contact: Yvonne Lafary 317-964-5253
• Principal Investigator: David Loesch, MD

United States, South Carolina

Cancer Center of the Carolinas
Recruiting

• Greenville, South Carolina, United States, 29605
• Contact: Julie Martin, NP 864-679-3967 [email protected]
• Principal Investigator: Joe Stephenson, MD

United States, Texas

South Texas Oncology Hematology
Recruiting

• San Antonio, Texas, United States, 78229
• Contact: Annelies Burnley, BSn, RN, OCN 210-593-2634 [email protected]
• Principal Investigator: Lon Smith, MD

Tyler Cancer Center
Recruiting

• Tyler, Texas, United States, 75702
• Contact: Linda Dunklin 903-579-9867 [email protected]
• Principal Investigator: Donald Richards, MD

Sponsors and Collaborators

Scottsdale Healthcare

Translational Genomics Research Institute (TGen)

Investigators

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

More Information

• Study ID Numbers: SCRI-CA-001, SCRI-CA-001
• First Received: September 14, 2007
• Last Updated: September 18, 2007
• ClinicalTrials.gov Identifier: NCT00530192
• Health Authority: United States: Institutional Review Board

Keywords provided by Scottsdale Healthcare:

Refractory Cancer

Molecular Profile

ClinicalTrials.gov processed this record on February 05, 2008