Compositions and methods for the treatment of cancer

Abstract

This invention relates to compositions comprising thalidomide and another anti-cancer drug which can be used in the treatment or prevention of cancer. Preferred anti-cancer drugs are topoisomerase inhibitors. A particular composition comprises thalidomide, or a pharmaceutically acceptable salt, solvate, or clathrate thereof, and irinotecan. The invention also relates to methods of treating or preventing cancer which comprise the administration of a thalidomide and another anti-cancer drug to a patient in need of such treatment or prevention. The invention further relates to methods of reducing or avoiding adverse side effects associated with the administration of chemotherapy or radiation therapy which comprise the administration of thalidomide to a patient in need of such reduction or avoidance.

1 - 60 . (canceled)  
     
     
         61 . A method for treating multiple myeloma in a subject comprising administering an amino analogue of thalidomide in combination with irinotecan.  
     
     
         62 . The method of  claim 61 , wherein the irinotecan is a pharmaceutically acceptable salt.  
     
     
         63 . The method of  claim 62 , wherein the pharmaceutically acceptable salt of irinotecan is a hydrochloride salt.  
     
     
         64 . The method of  claim 63 , wherein the irinotecan hydrochloride salt is CPT- 11.  
     
     
         65 . The method of  claim 61 , wherein the irinotecan is administered as an oral dosage form.  
     
     
         66 . The method of  claim 61 , wherein the amino analogue of thalidomide is administered as an oral dosage form.  
     
     
         67 . The method of  claim 61 , wherein the amino analogue of thalidomide and irinotecan are administered sequentially.  
     
     
         68 . The method of  claim 67 , wherein amino analogue of thalidomide and irinotecan are administered sequentially in any order.  
     
     
         69 . The method of claim  1 , wherein the amino analogue of thalidomide and irinotecan are administered simultaneously.  
     
     
         70 . The method of  claim 61 , wherein the subject has had prior chemotherapy.  
     
     
         71 . The method of  claim 70 , wherein the prior chemotherapy comprises treatment with MP, VAD, or treatment with one or more alkylating agents.  
     
     
         72 . The method of  claim 70 , wherein the prior chemotherapy comprises treatment with cyclophosphamide and etoposide, or treatment with etoposide, dexamethasone and doxorubicin.  
     
     
         73 . The method of  claim 70 , wherein amino analogue of thalidomide and irinotecan are administered sequentially, in any order.  
     
     
         74 . The method of  claim 70 , wherein amino analogue of thalidomide and irinotecan are administered simultaneously.  
     
     
         75 . A pharmaceutical preparation for the treatment of multiple myeloma comprising an amino analogue of thalidomide and irinotecan.  
     
     
         76 . The pharmaceutical preparation of  claim 75  wherein the the amino analogue of thalidomide and irinotecan are provided in a single dosage device.  
     
     
         77 . The pharmaceutical preparation of  claim 75  wherein the amino analogue of thalidomide and the irinotecan are provided in separate dosage devices.  
     
     
         78 . A method for treating multiple myeloma in a patient comprising administering an oral amino analogue of thalidomide in combination with oral irinotecan.  
     
     
         79 . The method of  claim 78 , wherein the irinotecan is a pharmaceutically acceptable salt form.  
     
     
         80 . The method of  claim 79 , wherein the pharmaceutically acceptable salt form of irinotecan is a hydrochloride salt.  
     
     
         81 . The method of  claim 80 , wherein the irinotecan hydrochloride salt is CPT-11.  
     
     
         82 . The method of  claim 78 , wherein the amino analogue of thalidomide and irinotecan are administered sequentially.  
     
     
         83 . The method of  claim 82 , where the amino analogue of thalidomide and irinotecan are administered sequentially in any order.  
     
     
         84 . The method of  claim 78 , wherein the amino analogue of thalidomide and irinotecan are administered simultaneously.