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Molecular Profiling Protocol (SCRI-CA-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00530192
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : July 10, 2009
Sponsor:
Collaborator:
Translational Genomics Research Institute
Information provided by:
Scottsdale Healthcare

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Refractory Cancer Other: Treatment based on Molecular Profiling Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers
Study Start Date : September 2006
Actual Primary Completion Date : March 2009
Study Completion Date : March 2009
Arms and Interventions
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Intervention Details:
  • Other: Treatment based on Molecular Profiling
    Treatment with commercially available treatments (per package insert instructions)

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530192


Locations
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United States, Alabama
Oncology Specialties
Huntsville, Alabama, United States, 35805
United States, Arizona
TGen Clinical Research Services
Scottsdale, Arizona, United States, 85258
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Tower Oncology
Beverly Hills, California, United States, 90211
Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Indiana
Central Indiana Cancer Center
Indianapolis, Indiana, United States, 46227
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
South Texas Oncology Hematology
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Scottsdale Healthcare
Translational Genomics Research Institute
Investigators
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Principal Investigator: Daniel D Von Hoff, MD TGen Clinical Research Services at Scottsdale Healthcare
More Information
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Responsible Party: Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT00530192    
Other Study ID Numbers: SCRI-CA-001
SCRI-CA-001
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009
Keywords provided by Scottsdale Healthcare:
Refractory Cancer
Molecular Profile