Intratumorally administered lactoferrin in the treatment of malignantneoplasms and other hyperproliferative diseases

Abstract

The present invention relates to methods of treating a hyperproliferative disease by administering a composition of lactoferrin alone or in combination with standard anti-cancer therapies.

1 . A method of treating an established solid neoplasm selected from the group consisting of Squamous cell carcinoma, Breast cancer, lung cancer, Renal cell carcinoma and combinations thereof, the method comprising the step of administering intratumorally to a human subject a human lactoferrin composition in an amount sufficient to reduce the rate of growth or shrink the established solid neoplasm in the human subject. 
   
   
       2 . The method of  claim 1 , wherein the established solid neoplasm is selected from the group consisting of lung cancer, Renal cell carcinoma and combinations thereof and wherein the method comprises the step of administering the lactoferrin composition as a monotherapy or in combination with a therapeutically effective surgery, radiotherapy and/or cytotoxic chemotherapy. 
   
   
       3 . The method of  claim 2 , wherein the established solid neoplasm is Renal cell carcinoma and the method comprises the step of administering the lactoferrin composition as a monotherapy. 
   
   
       4 . The method of  claim 2 , wherein the established solid neoplasm is lung cancer and the method comprises the step of administering the lactoferrin composition in combination with a chemotherapeutic agent selected from the group consisting of cytotoxic platinum drugs, taxanes and combinations thereof. 
   
   
       5 . The method of  claim 4 , wherein the chemotherapeutic agent is selected from the group consisting of paclitaxel, carboplatin and combinations thereof. 
   
   
       6 . The method of  claim 1 , wherein the established solid neoplasm is Breast cancer and the method comprises the step of administering the lactoferrin composition as a monotherapy or in combination with Gemcitabine. 
   
   
       7 . The method of  claim 1 , wherein the established solid neoplasm is Squamous cell carcinoma and the method comprises the step of administering the human lactoferrin composition as a monotherapy or in combination with a therapeutically effective surgery, radiotherapy and/or cytotoxic chemotherapy. 
   
   
       8 . The method of  claim 7 , wherein the human lactoferrin composition is administered in combination with a chemotherapeutic agent selected from the group consisting of cytotoxic platinum drugs, taxanes and combinations thereof. 
   
   
       9 . The method of  claim 8 , wherein the chemotherapeutic agent is selected from the group consisting of docetaxel, cisplatin and combinations thereof. 
   
   
       10 . The method of  claim 1 , wherein the established solid neoplasm is Squamous cell carcinoma and the method comprises the step of administering the lactoferrin composition in combination with radiotherapy. 
   
   
       11 . The method of  claim 1 , wherein the amount of the human lactoferrin composition that is administered is about 0.1 μg to about 10 g per day. 
   
   
       12 . The method of  claim 1 , further comprising administering a therapeutically effective amount of a cytotoxic chemotherapeutic agent selected from the group consisting of docetaxel, paclitaxel, carboplatin, cisplatin, Gemcitabine and combinations thereof.