Method of therapy

Abstract

Numerous diseases have been linked to the production of regulator cells. The present invention relates to the observation that the immune system is cycling in these diseases. Based on these observations, the present invention provides methods for treating diseases such as cancer and a HIV infection. The present invention also relates to methods of determining when a therapy to treat a disease characterized by the production of regulator cells should be administered to a patient.

1 - 44 . (canceled) 
     
     
         45 . A method for determining when to administer an agent to a squamous cell carcinoma patient, comprising:
 a. measuring c-reactive protein (CRP) in a patient suffering from squamous cell carcinoma, or samples obtained therefrom, wherein the measuring is conducted for a period of time that represents at least one cycle of persistent CRP cycling;   b. analyzing the results from step (a) to determine or predict a peak in the CRP cycling; and   c. determining when the agent is to be administered to the squamous cell carcinoma patient based on the cycling of the acute phase inflammatory marker, wherein the agent is to be administered in a two day window encompassing the determined or predicted peak in the cycling of the acute phase inflammatory marker and wherein the agent is an anti-proliferative drug selected from the group consisting of anti-metabolites and alkylating agents.   
     
     
         46 . The method of  claim 45 , wherein the anti-metabolite is selected from the group consisting of methotrexate, fluorouracil, floxuridine, cytarabine, mercaptopurine, thioguanine, pentostatin and hydroxyurea. 
     
     
         47 . The method of  claim 45 , wherein the alkylating agent is selected from the group consisting of carboplatin, mechlorethamine, cyclophosphamide, ifosfamide, melphalan, chlorambucil, hexamethyl-melamine, thiotepa, busulfan, carmustine, lomustine, semustine, streptozocin, dacarbazine, cisplatin and procarbazine. 
     
     
         48 . The method of  claim 45 , wherein the anti-proliferative drug is selected from the group consisting of 5-fluorouracil, carboplatin and combinations thereof. 
     
     
         49 . The method of  claim 45 , wherein the squamous cell carcinoma is squamous cell carcinoma of oesophagus. 
     
     
         50 . The method of  claim 45 , wherein the measuring is conducted for a period of at least about 21 days. 
     
     
         51 . The method of  claim 45 , wherein the measuring is conducted at least once about every 3 days. 
     
     
         52 . The method of  claim 45 , wherein the patient has not been exposed to a treatment for the squamous cell carcinoma for at least about 21 days. 
     
     
         53 . The method of  claim 45 , wherein the patient is a human. 
     
     
         54 . A method for determining when to administer an agent to a cancer patient, comprising:
 a. measuring an acute phase inflammatory marker in a patient suffering from cancer, or samples obtained therefrom, wherein the measuring is conducted for a period of time that represents at least one cycle of persistent acute phase inflammatory marker cycling;   b. analyzing the results from step (a) to determine or predict a peak in the acute phase inflammatory marker cycling; and   c. determining when the agent is to be administered to the cancer patient based on the cycling of the acute phase inflammatory marker, wherein the agent is to be administered in a two day window encompassing the determined or predicted peak in the cycling of the acute phase inflammatory marker.   
     
     
         55 . The method of  claim 54 , wherein the agent is selected from the group consisting of anti-proliferative drugs, radiation, and antibodies. 
     
     
         56 . The method of  claim 54 , wherein the measuring is conducted for a period of at least about 21 days. 
     
     
         57 . The method of  claim 54 , wherein the measuring is conducted at least once about every 3 days. 
     
     
         58 . The method of  claim 54 , wherein the patient has not been exposed to a treatment for the squamous cell carcinoma for at least about 21 days. 
     
     
         59 . The method of  claim 54 , wherein the patient is a human.