Clinical trial NCT00530192: Molecular Profiling Protocol (SCRI-CA-001)
Official title: A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Refractory Cancer
Keywords: Refractory Cancer
Molecular Profile
Lead sponsor: Scottsdale Healthcare
Sponsor class: OTHER
Collaborators: name: Translational Genomics Research Institute
First posted: 2007-09-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Every 8 weeks disease assessments are performed
Secondary outcomes:
measure: 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.
timeFrame: Time of Profiling- Baseline
measure: 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.
timeFrame: 4 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Oncology Specialties
state: Alabama
city: Scottsdale
country: United States
facility: TGen Clinical Research Services
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Oncology
state: California
city: Los Angeles
country: United States
facility: Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center
state: California
city: Indianapolis
country: United States
facility: Central Indiana Cancer Center
state: Indiana
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: San Antonio
country: United States
facility: South Texas Oncology Hematology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
Study officials:
affiliation: TGen Clinical Research Services at Scottsdale Healthcare
name: Daniel D Von Hoff, MD
role: PRINCIPAL_INVESTIGATOR
References: