Combination therapy for the treatment of tumors

Abstract

The present invention relates to a combination therapy method for treating gastrin-dependent tumors. The method comprises the immunization of a patient with an anti-gastrin 17 immunogenic composition in combination with the administration of chemotherapeutic agents such as 5-fluorouracil and leucovorin.

1 . A combination of anti-gastrin-dependent tumor therapeutic ingredients, comprising:
 (i) an immunogen directed against gastrin; and   (ii) one or more chemotherapeutic agents.   
     
     
         2 . The combination of  claim 1 , wherein the immunogen comprises a therapeutically effective amount of an anti-gastrin-17 (G17) peptide-containing immunogen. 
     
     
         3 . The combination of  claim 2 , wherein the anti-gastrin G17 immunogen is conjugated to a Diphtheria toxoid. 
     
     
         4 . The combination of  claim 2 , wherein the anti-gastrin G17 immunogen further comprises a spacer peptide. 
     
     
         5 . The combination of  claim 2 , wherein the anti-gastrin G17 immunogen further comprises a peptide that has the sequence of amino acid residues pGlu-Gly-Pro-Trp-Leu-Glu-Glu-Glu-Glu as set forth in SEQ ID NO: 1. 
     
     
         6 . The combination of  claim 2 , wherein the chemotherapeutic agent is selected from the group consisting of 5-fluorouracil, leucovorin, levamisole, cisplatin, tumor necrosis factor, and proglumide. 
     
     
         7 . The combination of  claim 1 , wherein each of the immunogen and the one or more chemotherapeutic agents comprises a pharmaceutically acceptable carrier. 
     
     
         8 . A method of treatment of a gastrin-dependent tumor, comprising administering to a patient in need thereof the components of the combination of  claim 1  to thereby treat the gastrin-dependent tumor in the patient. 
     
     
         9 - 18 . (canceled) 
     
     
         19 . The method of  claim 8 , wherein the method comprises:
 administering to the patient an anti-gastrin-17 (G17) immunogen to immunologically neutralize gastrin in the patient; and   administering to the patient an effective amount of one or more chemotherapeutic agents.   
     
     
         20 . The method of  claim 19 , wherein the immunogen comprises a gastrin G17-peptide. 
     
     
         21 . The method of  claim 20 , wherein the gastrin G17-peptide is conjugated to a diphtheria toxoid carrier. 
     
     
         22 . The method of  claim 20 , wherein the immunogen comprises the gastrin G17 peptide, a protein carrier and a spacer peptide that projects the gastrin G17-peptide away from the protein carrier and enhances capacity to bind lymphocyte receptors. 
     
     
         23 . The method of  claim 19 , wherein the gastrin G17-peptide comprises the sequence of amino acids set forth in SEQ ID NO: 1. 
     
     
         24 . The method of  claim 20 , wherein the gastrin G17-peptide comprises the sequence of amino acids set forth in SEQ ID NO: 1. 
     
     
         25 . The method of  claim 19 , wherein the chemotherapeutic agents are selected from among 5-fluorouracil, leucovorin, levamisole, cisplatin, tumor necrosis factor and proglumide. 
     
     
         26 . The method of  claim 19 , wherein the chemotherapeutic agent is 5-fluorouracil or leucovorin. 
     
     
         27 . The method of  claim 19 , wherein the anti-gastrin-17 immunogen is administered prior to administration of the chemotherapeutic agent. 
     
     
         28 . The method of  claim 26 , wherein the anti-gastrin-17 immunogen is administered prior to administration of the chemotherapeutic agent. 
     
     
         29 . The method of  claim 19 , wherein a chemotherapeutic agent is administered in several cycles. 
     
     
         30 . The combination of  claim 1 , wherein the immunogen and the one or more chemotherapeutic agents are in separate compositions. 
     
     
         31 . The combination of  claim 1 , wherein the immunogen and the one or more chemotherapeutic agents are formulated in the same composition.