Molecular Profiling Protocol (SCRI-CA-001)

Refractory Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530192
• Other study ID #: SCRI-CA-001
• Secondary ID: SCRI-CA-001
• Status: Completed
• Phase: Phase 0
• First received: September 14, 2007
• Last updated: July 9, 2009
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: Scottsdale Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractory Cancer

Intervention

Other:
• Treatment based on Molecular Profiling
Treatment with commercially available treatments (per package insert instructions)

Locations

Country	Name	City	State
United States	Tower Oncology	Beverly Hills	California
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Oncology Specialties	Huntsville	Alabama
United States	Central Indiana Cancer Center	Indianapolis	Indiana
United States	Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center	Los Angeles	California
United States	South Texas Oncology Hematology	San Antonio	Texas
United States	Mayo Clinic	Scottsdale	Arizona
United States	TGen Clinical Research Services	Scottsdale	Arizona
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Scottsdale Healthcare	Translational Genomics Research Institute, Phoenix, Arizona.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Every 8 weeks disease assessments are performed	No
Secondary	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 of Profiling- Baseline
Secondary	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.		4 months