Molecular Profiling Protocol (SCRI-CA-001)

Completed · Early Phase 1

Conditions studied: Refractory Cancer

In brief

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.

Key facts

Study ID

NCT00530192

Run by

Scottsdale Healthcare

People needed

86

Starts

2006-09-01

Expected to finish

2009-03-01

Last updated by the study team

2009-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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