Treatment of Cancer with Glufosfamide in Patients Not Receiving Insulin Therapy

Abstract

The co-administration of glufosfamide and a glucose lowering drug other than insulin is efficacious in cancer treatment.

1 . A method of treating cancer in a patient, comprising the steps of:
 (i) determining whether a patient is receiving insulin therapy, and, if so, then   (ii) discontinuing the insulin therapy, before   (iii) administering a therapeutically effective amount of glufosfamide to the patient.   
     
     
         2 . The method of  claim 1 , wherein the cancer is primary pancreatic cancer 
     
     
         3 . The method of  claim 1 , wherein the cancer is chemotherapy resistant pancreatic cancer. 
     
     
         4 . The method of  claim 1 , wherein the cancer is pancreatic cancer that has previously been treated unsuccessfully with a chemotherapeutic agent other than glufosfamide. 
     
     
         5 . The method of  claim 1 , wherein the patient has a normal glucose level at the time administration of the blood glucose lowering drug is initiated. 
     
     
         6 . The method of  claim 1 , further comprising administering to the patient a blood glucose lowering drug other than insulin. 
     
     
         7 . A method of treating cancer in a patient, comprising
 (i) determining if the patient is receiving a glucose lowering drug other than insulin;   (ii) initiating administration of a glucose lowering drug other than insulin if the patient is not already receiving such drug; and   (iii) administering a therapeutically effective amount of glufosfamide to the patient.   
     
     
         8 . The method of  claim 7 , wherein the cancer is primary pancreatic cancer 
     
     
         9 . The method of  claim 7 , wherein the cancer is chemotherapy resistant pancreatic cancer. 
     
     
         10 . The method of  claim 7 , wherein the cancer is pancreatic cancer that has previously been treated unsuccessfully with a chemotherapeutic agent other than glufosfamide. 
     
     
         11 . The method of  claim 7 , wherein the glucose lowering agent is a sulfonylurea. 
     
     
         12 . The method of  claim 7 , wherein the glucose lowering agent is a thiazolidinedione. 
     
     
         13 . The method of  claim 7 , wherein the glucose lowering drug is selected from glipizide, glibenclamide, glimepiride, gliclazide, and rosiglitazone. 
     
     
         14 . The method of  claim 7 , wherein the glucose lowering drug is selected from acetohexamide, chloropropamide, metformin, nateglinide, pioglitazone, repaglinide, tolazamide, and tolbutamide. 
     
     
         15 . The method of  claim 7 , further comprising
 (iv) determining whether a patient is receiving insulin therapy, and, if so, then   (v) discontinuing the insulin therapy before administering the glufosfamide.   
     
     
         16 . A method of determining whether a cancer in a cancer patient is susceptible to treatment with glufosfamide, the method comprising:
 (a) measuring the level of IGF-1 in the cancer patient,   (b) determining that if the level of the IGF-1 measured in step (a) is larger than a predetermined level of IGF-1, the cancer is susceptible to treatment with glufosfamide, optionally in combination with a glucose lowering agent other than insulin.   
     
     
         17 . A method of determining whether a cancer in a cancer patient is susceptible to treatment with glufosfamide, the method comprising:
 (a) measuring the level of a glucosidase in the cancer patient,   (b) determining that if the level of the glucosidase measured in step (a) is larger than a predetermined level of the glucosidase, the cancer is susceptible to treatment with glufosfamide, optionally in combination with a glucose lowering agent other than insulin.   
     
     
         18 . The method of  claim 16 , comprising measuring both the level of IGF-1 and the level of glucosidase in the cancer patient. 
     
     
         19 . The method of  claim 16 , further comprising administering to the patient a therapeutically effective combination of glufosfamide and IGF-1. 
     
     
         20 . The method of  claim 17 , further comprising administering to the patient a therapeutically effective combination of glufosfamide and a glucosidase.