Bladder cancer treatment and methods

Abstract

Therapeutic compositions comprising an indoloquinone compound and various bladder cancer treatments and methods are disclosed. More specifically, bladder cancer treatments include the intravesical administration of apaziquone immediately following transurethral resection. Also disclosed are therapeutic compositions comprising an indoloquinone compound and a formulation vehicle. The formulation vehicle improves the solubility and stability of the indoloquinone compound. Additionally, the coating compositions can include coating agents that provide better adhesion of the coating composition to the bladder wall during intravesical delivery of the coating composition.

What is claimed is: 
     
         1 . A method of treating bladder cancer comprising administering a therapeutic composition comprising a therapeutic amount of Apaziquone after transurethral resection of bladder tumor (TUR-BT). 
     
     
         2 . The method according to  claim 1  wherein said administering is via intravesical instillation. 
     
     
         3 . The method according to  claim 1 , wherein said administering occurs within about 6 hours following TUR-BT. 
     
     
         4 . The method according to  claim 1 , wherein said administering occurs within about 5 hours following TUR-BT. 
     
     
         5 . The method according to  claim 1 , wherein said administering occurs within about 4 hours following TUR-BT. 
     
     
         6 . The method according to  claim 1 , wherein said administering occurs within about 3 hours following TUR-BT. 
     
     
         7 . The method according to  claim 1 , wherein said bladder cancer is non-invasive bladder cancer. 
     
     
         8 . The method according to  claim 1 , wherein said bladder cancer is transitional-cell carcinoma of the bladder. 
     
     
         9 . The method according to  claim 1 , wherein said bladder cancer is TNM stage Ta or T1. 
     
     
         10 . The method according to  claim 1 , wherein said bladder cancer is histologic grade G1 or G2. 
     
     
         11 . The method according to  claim 1 , wherein said therapeutic composition comprises from about 1 mg to about 8 mg per dose Apaziquone. 
     
     
         12 . The method according to  claim 1 , wherein said therapeutic composition comprises from about 2 mg to about 6 mg per dose Apaziquone. 
     
     
         13 . The method according to  claim 1 , wherein said therapeutic composition comprises from about 3 mg to about 5 mg per dose Apaziquone. 
     
     
         14 . The method according to  claim 1 , wherein the therapeutic composition comprises about 300 μM to about 400 μM Apaziquone, about 6% (v/v) to about 34% (v/v) propylene glycol, about 1 mg/mL to about 20 mg/mL sodium bicarbonate, about 0.5 mg/mL to about 3.0 mg/mL mannitol, EDTA and water. 
     
     
         15 . The method according to  claim 14 , wherein the therapeutic composition comprises about a 347 μM Apaziquone, about 30% (v/v) propylene glycol, about 5.125 mg/mL sodium bicarbonate, and about 1.25 mg/mL mannitol. 
     
     
         16 . A method of treating bladder cancer comprising the steps of:
 (a) performing transurethral resection of a bladder tumor in patients in need thereof;   (b) administering via intravesical instillation a therapeutically effective amount of Apaziquone.   
     
     
         17 . The method according to  claim 16 , wherein the therapeutically effective amount of Apaziquone is from about 1 mg to about 8 mg per dose 
     
     
         18 . The method according to  claim 16 , wherein the therapeutic composition comprises about 300 μM to about 400 μM Apaziquone, about 6% (v/v) to about 34% (v/v) propylene glycol, about 1 mg/mL to about 20 mg/mL sodium bicarbonate, about 0.5 mg/mL to about 3.0 mg/mL mannitol, EDTA and water. 
     
     
         19 . The method according to  claim 18 , wherein said preparation has a pH range of 8.5 to 9.5. 
     
     
         20 . The method according to  claim 18 , wherein the therapeutic composition comprises about a 347 μM Apaziquone, about 30% (v/v) propylene glycol, about 5.125 mg/mL sodium bicarbonate, and about 1.25 mg/mL mannitol.