This protocol provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors. D-1MT, or any other substance targeting this enzymatic pathway indoleamine-(2,3)-dioxygenase (IDO), has not been used previously in humans. Although pre-clinical toxicology in rats and dogs shows an extremely encouraging toxicity profile, the study needs to carefully evaluate the toxicities and pharmacokinetics to provide the basis for assigning a safe and biologically effective dosing regimen for later trials determining its contribution to tumor responses in phase II and III clinical trials.
This study provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors.