Methods and kits for diagnosis of cancer and prediction of therapeutic value

Abstract

A method for identifying a patient for cancer therapy can include administering a diagnostic dose of a detectably labeled first binding agent to a patient, the detectably labeled binding agent being capable of binding a molecular target. The method also includes selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a cellular target, wherein the selected patient exhibits a positive reading for the detectably labeled first binding agent. Furthermore, the method can include administering a therapeutic dose of the second binding agent to the patient.

1 . A method for identifying a patient for cancer therapy comprising:
 providing a first binding agent comprising a detectable label capable of binding a first molecular target, wherein the first molecular target is selected from a pathway related to cancer;   assessing the presence of the first binding agent in a tissue, cells or bodily fluid in a patient; the assessing comprises quantifying an amount of the first molecular target;   selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a second molecular target, wherein the patient is selected if the first binding agent is present.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1  wherein the step of assessing further comprises
 administering the patient with a diagnostic dose of the detectably labeled first binding agent, the detectably labeled binding agent being capable of binding the first molecular target; and 
 in vivo imaging the detectably labeled first binding agent in the patient. 
 
     
     
         4 . The method of  claim 3  wherein the detectably labeled first binding agent is detected by radioscintigraphy, magnetic resonance imaging (MRI), computed tomography (CT scan), or positron emission tomography (PET). 
     
     
         5 . The method of  claim 1  wherein the step of assessing further comprises
 contacting a biological sample obtained from the patient with the first binding agent; and 
 assaying for the presence of the first binding agent. 
 
     
     
         6 . The method of  claim 1  wherein the first and the second molecular target are substantially the same. 
     
     
         7 . The method of  claim 1  wherein the first and the second molecular target are component of the same pathway related to cancer. 
     
     
         8 . The method of  claim 1  wherein the cancer is a prostate cancer and wherein the first binding agent is capable of binding to an extracellular domain of Prostate Specific Membrane Antigen (PSMA). 
     
     
         9 . The method of  claim 1  wherein the first binding agent is capable of binding to an extracellular domain of Prostate Specific Membrane Antigen (PSMA) in the neo-vasculature of a solid tumor. 
     
     
         10 . The method of  claim 2 , wherein the detectably labeled agent comprises a Positron Emission Tomography (PET) agent. 
     
     
         11 . The method of  claim 1  wherein the first or second binding agent comprises a radiolabel that is at least one of  177 Lu,  111 Indium,  67 Cu,  18 F,  99m Tc,  124 I,  125 I,  131 I,  89 Zr, and  99m Tc. 
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 1  wherein the first or second binding agent comprises an antibody or antigen binding portion or derivative thereof capable of binding the extracellular domain of PSMA. 
     
     
         14 . The method of  claim 13 , wherein the antibody or antigen binding portion or derivative
 thereof comprises a monoclonal antibody or antigen binding portion or derivative thereof produced by a hybridoma selected from the group consisting of a hybridoma deposited under ATCC deposit accession number HB-12101, a hybridoma deposited under ATCC deposit accession number HB-12109, a hybridoma deposited under ATCC deposit accession number HB-12127, and a hybridoma deposited under ATCC deposit accession number HB-12126.   
     
     
         15 . The method of  claim 1  wherein the first or second binding agent has an affinity of at least about 10 −9  M for at least the first or the second molecular target. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 3  further comprising administering an image contrast agent in conjunction with the diagnostic dose of a detectably labeled first binding agent. 
     
     
         18 . The method of  claim 1  further comprising administering a therapeutic dose of the second binding agent to the patient. 
     
     
         19 . A kit for cancer therapy comprising:
 a detectably labeled first binding agent, the detectably labeled binding agent being capable of binding a molecular target comprising an extracellular domain of Prostate Specific Membrane Antigen (PSMA); and   instruction for selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a second molecular target, wherein the selected patient exhibits a positive reading for the detectably labeled first binding agent.   
     
     
         20 . (canceled) 
     
     
         21 . The kit of  claim 19  further comprising a therapeutic dose of the second binding agent. 
     
     
         22 . The kit of  claim 19  further comprising an image contrast agent. 
     
     
         23 . (canceled) 
     
     
         24 . A method for treating cancer comprising:
 selecting a first and a second molecular target from a pathway related to prostate cancer;   assessing the presence of a detectably labeled first binding agent in a tissue, cell or bodily fluid in a patient, wherein the first binding agent is capable of binding a first molecular target and wherein the presence of the first binding agent is indicative of cancer;   administering a therapeutic dose of a second binding agent capable of binding a second molecular target to a selected patient, wherein the patient is selected if the first binding agent is present, wherein the molecular target comprises an extracellular domain of Prostate Specific Membrane Antigen (PSMA).   
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 24  wherein the first and second molecular targets are substantially the same.