Method to improve safety and efficacy of anti-cancer therapy

Abstract

The invention relates to the use of a deoxyribonuclease (DNase) enzyme for prevention or amelioration of toxicity associated with various cytostatic and/or cytotoxic chemotherapeutic compounds and radiation therapy.

1 .- 18 . (canceled) 
     
     
         19 . A method for preventing or ameliorating a toxicity associated with a radiation therapy in a subject suffering from a cancer and receiving said radiation therapy, which method comprises administering to the subject a therapeutically effective amount of a DNase enzyme, wherein said amount of the DNase enzyme is effective to prevent or ameliorate at least one side effect of said radiation therapy. 
     
     
         20 . The method of  claim 19 , wherein said amount of the DNase enzyme is effective to increase the efficacy of a radiation therapy in the subject. 
     
     
         21 . The method of  claim 19 , wherein said side effect of said radiation therapy is selected from the group consisting of body weight loss, skin irritation or damage, fatigue, nausea, vomiting, fibrosis, bowel damage, memory loss, infertility, and a second cancer. 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 19 , wherein said radiation therapy is external beam radiation therapy or systemic radioisotope therapy. 
     
     
         24 . The method of  claim 19 , wherein the DNase enzyme is administered during a cycle of the radiation therapy. 
     
     
         25 . The method of  claim 19 , wherein the DNase enzyme is administered after a cycle of the radiation therapy. 
     
     
         26 . The method of  claim 19 , wherein the DNase enzyme is DNase I or an analogue thereof. 
     
     
         27 . The method of  claim 26 , wherein the DNase I enzyme analogue is DNase gamma. 
     
     
         28 . The method of  claim 26 , wherein the DNase I enzyme is human recombinant DNase I. 
     
     
         29 . The method of  claim 19 , wherein the DNase enzyme is DNase II. 
     
     
         30 . The method of  claim 19 , wherein the DNase enzyme has an extended half-life. 
     
     
         31 . The method of  claim 19 , wherein the therapeutically effective amount of the DNase enzyme is within the range 0.5-50 mg/kg/day. 
     
     
         32 . The method of  claim 31 , wherein the therapeutically effective amount of the DNase enzyme is within the range 1.5-50 mg/kg/day. 
     
     
         33 . The method of  claim 31 , wherein the therapeutically effective amount of the DNase enzyme is within the range 10-50 mg/kg/day. 
     
     
         34 . The method of  claim 19 , wherein the DNase enzyme is administered intravenously or intraperitoneally. 
     
     
         35 . The method of  claim 19 , wherein the DNase enzyme is administered enterally. 
     
     
         36 . The method of  claim 34 , wherein the DNase enzyme is administered orally. 
     
     
         37 . The method of  claim 19 , wherein the subject is human. 
     
     
         38 . The method of  claim 19 , further comprising monitoring changes in said at least one side effect of said radiation therapy after DNase enzyme administration.