C. novyi for the treatment of solid tumors in humans

Abstract

The present invention provides, inter alia, methods for treating or ameliorating an effect of a solid tumor present in a human. These methods include administering intratumorally to the human a unit dose of C. novyi, preferably C. novyi NT, colony forming units (CFUs), which contains about 1×103-1×107 CFUs suspended in a pharmaceutically acceptable carrier or solution. Methods for debulking a solid tumor present in a human, methods for ablating a solid tumor present in a human, a method for microscopically precise excision of tumor cells in a human, methods for treating or ameliorating an effect of a solid tumor that has metastasized to one or more sites in a human, unit doses of C. novyi, preferably C. novyi NT, CFUs, and kits for treating or ameliorating an effect of a solid tumor present in a human are also provided.

What is claimed is: 
     
         1 . A unit dose of  C. novyi  colony forming units (CFUs) for debulking or abalating a solid tumor present in a human, comprising about 1×10 3 -1×10 6  CFUs in a pharmaceutically acceptable carrier or solution. 
     
     
         2 . The unit dose of  claim 1 , wherein the solid tumor is selected from the group consisting of soft tissue sarcoma, hepatocellular carcinoma, breast cancer, pancreatic cancer, and melanoma. 
     
     
         3 . The unit dose of  claim 1 , wherein the solid tumor is leiomyosarcoma. 
     
     
         4 . The unit dose of  claim 3 , wherein the solid tumor is retroperitoneal leiomyosarcoma. 
     
     
         5 . The unit dose of  claim 1 , wherein the  C. novyi  CFUs are selected from the group consisting of vegetative and spore forms. 
     
     
         6 . The unit dose of  claim 1 , wherein the  C. novyi  is  C. novyi  NT. 
     
     
         7 . The unit dose of  claim 6 , wherein the unit dose comprises about 1×10 4    C. novyi  NT spores in a pharmaceutically acceptable carrier or solution. 
     
     
         8 . The unit dose of  claim 1 , wherein the unit dose is formulated for intratumoral administration. 
     
     
         9 . The unit dose of  claim 1 , wherein the unit dose is effective to debulk or ablate the solid tumor without administration of additional anti-cancer agents. 
     
     
         10 . The unit dose of  claim 1 , wherein the unit dose is effective to debulk or ablate the solid tumor by a single treatment. 
     
     
         11 . A unit dose of  C. novyi  colony forming units (CFUs) for microscopically precise excision of tumor cells in a human, comprising about 1×10 3 -1×10 6  CFUs in a pharmaceutically acceptable carrier or solution. 
     
     
         12 . The unit dose of  claim 11 , wherein the unit dose is effective for microscopically precise excision of tumor cells without administration of additional anti-cancer agents. 
     
     
         13 . A kit for debulking or abalating a solid tumor present in a human, comprising a unit dose according to  claim 1  and instructions for use of the kit. 
     
     
         14 . The kit of  claim 13 , further comprising one or more antibiotics, which are effective to treat or alleviate an adverse side effect caused by the  C. novyi  CFUs. 
     
     
         15 . The kit of  claim 13 , wherein the  C. novyi  CFUs are selected from the group consisting of vegetative and spore forms. 
     
     
         16 . The kit of  claim 13 , wherein the  C. novyi  is  C. novyi  NT. 
     
     
         17 . The kit of  claim 16 , wherein the unit dose comprises about 1×10 4    C. novyi  NT spores in a pharmaceutically acceptable carrier or solution. 
     
     
         18 . The kit of  13 , further comprising 1-4 unit doses of the  C. novyi  CFUs for carrying out 1-4 treatment cycles. 
     
     
         19 . The kit of  claim 17 , further comprising 1-4 unit doses of the  C. novyi  NT spores for carrying out 1-4 treatment cycles.