This section of the Weisenthal Cancer Group website pertains to a clinical study of personalized medicine.  The clinical study will use a combined technology approach called Functional Cellomic Profiling.  Functional cellomic profiling (which is abbreviated as FCP) involves testing of live cancer and endothelial cells (these cells form capillaries which bring oxygen and nutrients to cancer cells) obtained from each patient.  In this FCP personalized medicine study, a newly-developed anti-angiogenesis drug assay will be used along with previously-studied functional tumor cell profiling methods to identify the most promising in vitro combination of anti-angiogenesis drugs, targeted anti-kinase drugs, and standard chemotherapy agents for each patient in the study.  Treatments will be selected on a patient-by-patient basis with FCP results reported prospectively to treating physicians.  The study will seek to correlate treatment outcomes with FCP test results in order to assess the feasibility of FCP personalized medicine. 

Participant Qualifications

•             Patients with a diagnosis of cancer who are candidates for treatment with anti-cancer drugs (chemotherapy) potentially are eligible.  Other qualifications might apply.

Study Design

•             Living cancer and endothelial cells are obtained individually from each clinical trial participant.  Each participant's living cancer and endothelial cells are then exposed in the laboratory to a broad range of appropriate chemotherapy drugs. 

•             Drug panels which are selected for testing are customized for each study participant.  Included are relevant standard chemotherapy agents as well as newly-emergent targeted therapy drugs such as tyrosine kinase and angiogenesis-inhibiting agents. 

•             Drugs are tested for activity both as single agents and in rational drug combinations, in order to assess possible drug synergies.

•             Patterns of drug activity observed in the laboratory against each patient's own cancer ad endothelial cells are reported prospectively to treating physicians to aid in the design of personalized chemotherapy treatments.

What is new or different about this study?

•             This study involves the use of a new laboratory test that allows for simultaneous identification of anti-tumor activity and anti-vascular activity in established anti-cancer drug treatments and also in novel combinations of standard drugs, kinase-inhibiting drugs, and new anti-angiogenesis agents.

•             Progress of patients in the study is reported online in as close to real-time as possible.  (Note: Patient privacy is rigorously protected.  Study participants are assigned code numbers - actual patient identities are kept secret.) 

•             Online posting enables current and prospective trial participants to assess the possibility of clinical benefit from study participation.  (In most studies, participants have no way of knowing if any other patients in the study have benefitted from participation.)  It also allows cancer physicians to learn if specific drug regimens provided patient benefit without waiting months or years for final publication of study data. 

What is the aim of this study?

•             To obtain clinical outcomes (progression-free and overall survival) of patients who receive personalized treatments which are selected for them by their physicians with prior knowledge of drug activity observed in the laboratory against their own cancer cells and:  

•       To compare these outcomes with those of closely-matched patients (most of whom will not have undergone functional cellomic profiling ) reported by the National Cancer Institute (NIH) in its Surveillance Epidemiology and End Result (SEER) program.    

Additional Study Features   

•             No patient will be “randomized” to a secondary treatment arm. 

•             No patient will receive a placebo or other “control” therapy. 

•             Each patient will receive the individualized treatment which offers the highest probability of benefit, in the opinion of the treating physician.