Clinical Trials

 

To search for clinical trials for Leiomyosarcoma, go to http://clinicaltrials.gov. You can also search for “solid tumors” but this should be after you exhaust the list of trials that have been specific to LMS.


 

STEPS TO GET A NEW DRUG APPROVED (simplified)

 

The Federal Drug Administration (FDA) reviews then approves or disapproves each step of drug testing. It’s estimated to take 12 years and millions of dollars to go through these steps:

Preclinical testing (lab and animal.)
Phase 1 study (typically involves 20 to 80 people). Question to be answered: Is this treatment safe?
Phase 2 study (typically involves a 30 to about 100 people). Question to be answered: Is this effective and at what levels or dosage?
Phase 3 study (typically involves several hundred to about 300 people). Question to be answered: How effective is this compared to the existing approved treatments?

 


 

TYPES OF DRUGS AND TREATMENTS BEING TESTED IN TRIALS

 

Targeted Chemotherapy (molecular pathway and angiogenesis inhibitors, vascular disrupters)
Cytotoxic Chemotherapy (kills fast growing healthy & cancerous cells)
Immunotherapy (vaccines, viral or gene therapy)
Interventional Radiology (RFA, cryoablation, ultrasound, cyberknife)
Stem Cell
Combined Methods (chemo + radiation + surgery)

 


 

GLOSSARY

 

Here are a few important terms to know taken from the extensive glossary at ClinicalTrials.gov

Blind study:  the investigator or participant, or both, do not know which participants have been assigned which
Informed Consent:  A process in which researchers communicate with potential and enrolled participants about a clinical study.
Placebo:  A substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied.
Principal investigator (PI):  the person in charge of the study.
Protocol:  The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.