Nanoparticle comprising rapamycin and albumin as anticancer agent

Abstract

The present invention features methods for treating, stabilizing, preventing, and/or delaying cancer by administering nanoparticles that comprise rapamycin or a derivative thereof. The invention also provides compositions (e.g., unit dosage forms) comprising nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof. The invention further provides combination therapy methods of treating cancer comprising administering to an individual an effective amount of nanoparticles that comprise rapamycin or a derivative thereof and a second therapy.

1 . A method of treating cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles that comprise rapamycin or a derivative thereof and a carrier protein. 
     
     
         2 - 3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein the cancer is a plasmacytoma. 
     
     
         5 . The method of  claim 1 , wherein the cancer is selected from the group consisting of multiple myeloma, pancreatic cancer, renal cell carcinoma, prostate cancer, lung cancer, melanoma, and breast cancer. 
     
     
         6 . The method of  claim 1 , wherein the cancer is not colon cancer. 
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 5 , wherein the cancer is pancreatic cancer. 
     
     
         9 . The method of  claim 1 , wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 180 mg to about 270 mg. 
     
     
         10 - 15 . (canceled) 
     
     
         16 . The method of  claim 1 , wherein the carrier protein is albumin. 
     
     
         17 . The method of  claim 16 , wherein the albumin is human serum albumin. 
     
     
         18 . The method of  claim 1 , wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the individual is human. 
     
     
         21 . A unit dosage form for treatment of cancer comprising (a) nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof, wherein the amount of the rapamycin or derivative thereof in the unit dosage form is in the range of about 180 mg to about 270 mg, and (b) a pharmaceutically acceptable carrier. 
     
     
         22 - 31 . (canceled) 
     
     
         32 . A kit comprising (a) nanoparticles that comprise a carrier protein and rapamycin or a derivative thereof, wherein the amount of the rapamycin or derivative thereof in the kit is in the range of about 180 mg to about 270 mg, and (b) instructions for using the kit in treating cancer. 
     
     
         33 - 43 . (canceled) 
     
     
         44 . A method of treating cancer in an individual comprising (a) a first therapy comprising administering to the individual an effective amount of a composition comprising nanoparticles that comprise rapamycin or a derivative thereof and a carrier protein and (b) a second therapy selected from the group consisting of chemotherapy, radiation therapy, surgery, hormone therapy, gene therapy, immunotherapy, bone marrow transplantation, stem cell transplantation, targeted therapy, cryotherapy, ultrasound therapy, and immunotherapy. 
     
     
         45 . The method of  claim 44 , wherein the second therapy is chemotherapy. 
     
     
         46 . The method of  claim 45 , wherein chemotherapy comprises administration of a chemotherapeutic selected from the group consisting of antimetabolite agents, platinum-based agents, alkylating agents, tyrosine kinase inhibitors, anthracycline antibiotics, vinca alkloids, proteasome inhibitors, and topoisomerase inhibitors. 
     
     
         47 - 53 . (canceled) 
     
     
         54 . The method of  claim 44 , wherein the cancer is selected from the group consisting of multiple myeloma, pancreatic cancer, renal cell carcinoma, prostate cancer, lung cancer, melanoma, and breast cancer. 
     
     
         55 . The method of  claim 44 , wherein the cancer is not colon cancer. 
     
     
         56 - 57 . (canceled) 
     
     
         58 . The method of  claim 44 , wherein the amount of the rapamycin or derivative thereof in the effective amount of the composition is in the range of about 180 mg to about 270 mg. 
     
     
         59 - 61 . (canceled) 
     
     
         62 . The method of  claim 44 , wherein a taxane is not administered to the individual. 
     
     
         63 - 64 . (canceled) 
     
     
         65 . The method of  claim 44 , wherein the carrier protein is albumin. 
     
     
         66 . The method of  claim 44 , wherein the albumin is human serum albumin. 
     
     
         67 . The method of  claim 44 , wherein the average diameter of the nanoparticles in the composition is no greater than about 200 nm. 
     
     
         68 . (canceled) 
     
     
         69 . The method of  claim 44 , wherein the individual is human. 
     
     
         70 . The method of  claim 45 , wherein the chemotherapy comprises administering to the individual an inhibitor of the mTOR signaling pathway. 
     
     
         71 . The method of  claim 45 , wherein the chemotherapy comprises administering to the individual an AKT kinase inhibitor. 
     
     
         72 . The method of  claim 72 , wherein AKT kinase inhibitor is perifosine. 
     
     
         73 . The method of  claim 45 , wherein the chemotherapy comprises administering to the individual a tyrosine kinase inhibitor. 
     
     
         74 . The method of  claim 73 , wherein the tyrosine kinase inhibitor is erlotinib.