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 . The method of  claim 1 , wherein the cancer is early stage cancer, non-metastatic cancer, primary cancer, advanced cancer, locally advanced cancer, metastatic cancer, cancer in remission, recurrent cancer, cancer in an adjuvant setting, cancer in a neoadjuvant setting, or cancer substantially refractory to hormone therapy. 
     
     
         3 . The method of  claim 1 , wherein the cancer is a solid tumor. 
     
     
         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, renal cell carcinoma, prostate cancer, lung cancer, melanoma, and breast cancer. 
     
     
         6 - 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 . The method of  claim 1 , wherein the weight ratio of the carrier protein to the rapamycin or derivative thereof in the nanoparticle composition is no greater than about 18:1. 
     
     
         20 . The method of  claim 1 , wherein the individual is human. 
     
     
         21 - 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 . The method of  claim 45 , wherein chemotherapy comprises administration of a chemotherapeutic selected from the group consisting of adriamycin, colchicine, cyclophosphamide, actinomycin, bleomycin, duanorubicin, doxorubicin, epirubicin, mitomycin, methotrexate, mitoxantrone, fluorouracil, carboplatin, carmustine (BCNU), methyl CCNU, cisplatin, etoposide, interferons, camptothecin and derivatives thereof, phenesterine, topetecan, vinblastine, vincristine, tamoxifen, piposulfan, nab-5404, nab-5800, nab-5801, Irinotecan, HKP, Ortataxel, gemcitabine, Herceptin, vinorelbine, Doxil, capecitabine, Alimta, Avastin, Velcade, Tarceva, Neulasta, Lapatinib, and Sorafenib. 
     
     
         48 - 64 . (canceled) 
     
     
         65 . The method of  claim 44 , wherein the carrier protein is albumin. 
     
     
         66 . The method of  claim 65 , 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 . The method of  claim 44 , wherein the weight ratio of the carrier protein to the rapamycin or derivative thereof in the nanoparticle compositions is no greater than about 18:1. 
     
     
         69 . The method of  claim 44 , wherein the individual is human.