Methods, compositions, and kits for organ protection during systemic anticancer therapy

Abstract

Methods, compositions, and kits are presented for local tissue protection during systemic administration of anticancer therapeutic agents.

1 - 71 . (canceled) 
   
   
       72 . A topical formulation consisting of an emulsion of about 1% (w/w) uracil and one or more pharmaceutically acceptable carriers. 
   
   
       73 . The topical formulation of  claim 72 , wherein the pharmaceutically acceptable carrier is a water-in-oil or oil-in-water emulsion. 
   
   
       74 . The topical formulation of  claim 73 , wherein the emollient comprises polyols, esters, hydrocarbons, and mixtures thereof. 
   
   
       75 . The topical formulation of  claim 73 , wherein the polyols comprise propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol, sorbitol, hydroxypropyl sorbitol, hexylene glycol, 1,3-butylene glycol, 1,2,6-hexanetriol, glycerin, ethoxylated glycerin, propoxylated glycerin, xylitol and mixtures thereof. 
   
   
       75 . The topical formulation of  claim 73 , wherein the esters comprise alkyl esters of fatty acids having 10 to 20 carbon atoms. 
   
   
       76 . A method of treating skin surfaces of a human suffering from the adverse effects of one or more systemically distributed anticancer therapeutic agents or metabolites comprised of fluorouracil or a prodrug thereof without abrogating the clinical efficacy of said systemically distributed anticancer therapeutic agent or metabolite, comprising:
 administering a formulation comprising uracil to the skin surfaces in an amount effective to protect against the adverse effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof.   
   
   
       77 . The method of  claim 76 , wherein the skin surface is the palmar surface. 
   
   
       78 . The method of  claim 76 , wherein the skin surface is the plantar surface. 
   
   
       79 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 0.01% and less than about 20%. 
   
   
       80 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 0.01% and less than about 10%. 
   
   
       81 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 0.01% and less than about 5%. 
   
   
       82 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 0.01%. 
   
   
       83 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 0.1%. 
   
   
       84 . The method of  claim 76 , wherein the amount of uracil effective to protect against the effects of one or more systemically distributed anticancer therapeutic agents or metabolites thereof is at a amount by weight of least about 1%.