Method of Treating Patients with a Mucinous Glycoprotein (MUC-1) Vaccine

Abstract

The present invention provides a method for treating an individual who is afflicted with a cancer, such as non-small cell lung cancer or prostate cancer, by administering to that individual a MUC-1-based formulation. The formulation may be a MUC-1 based liposomal vaccine formulation.

1 - 28 . (canceled) 
     
     
         29 . A method for treating a subject with non-small lung cancer (NSCLC) comprising:
 (a) measuring the level of circulating tumor marker CA27.29 MUC-1 by enzyme-linked immunosorbent-, chemiluminescent- or radio-immunoassay in a subject having a cancer cell that expresses MUC-1;   (b) selecting for treatment a subject having a circulating CA27.29 (MUC-1) level of 37.7 U/ml or less; and   (c) administering to that subject, for a period of time, a MUC-1-based formulation, wherein the formulation comprises:
 (i) a liposome; and 
 (ii) a MUC-1 core repeat having an amino acid sequence which is at least 80% identical to SEQ ID NO: 2. 
   
     
     
         30 . (canceled) 
     
     
         31 . The method according to  claim 29 , wherein the formulation further comprises at least one adjuvant selected from the group consisting of lipid A, muramyl dipeptide, alum, acytokine, and a combination thereof. 
     
     
         32 . The method according to  claim 31 , wherein the lipid A is monophosphoryl lipid A or a synthetic lipid A. 
     
     
         33 . The method according to  claim 29 , further comprising a step (d) evaluating the treated subject. 
     
     
         34 . The method according to  claim 33 , wherein evaluating the treated subject is performed: (i) before the period of time of step (c); (ii) during the period of time of step (c); (iii) after the period of time of step (c); or (iv) a combination thereof. 
     
     
         35 . The method according to  claim 33 , wherein evaluating the treated subject comprises measuring an immune reaction in the treated subject. 
     
     
         36 . The method according to  claim 35 , wherein measuring the immune reaction in the treated subject comprises measuring a T-cell proliferation. 
     
     
         37 . The method according to  claim 29  , wherein the MUC-1-based formulation is provided in a kit. 
     
     
         38 . The method according to  claim 29 , wherein the step of administering is by injection, aerosol, nasal, vaginal, rectal, buccal, ocular, local, topical, intracisternal, intraperitoneal, or oral delivery, and wherein the injection is an intramuscular, intravenous, subcutaneous, intranodal, intratumoral, intraperitoneal, or intradermal injection. 
     
     
         39 . The method according to  claim 29 , wherein the period of time is selected from the group consisting of at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, at least about 16 weeks, at least about 17 weeks, at least about 18 weeks, at least about 19 weeks, at least about 20 weeks, al leasl about 24 weeks, at least about 28 weeks, at least about 32 weeks, at least about 36 weeks, at least about 40 weeks, at least about 44 weeks, at least about 48 weeks, at least about 52 weeks, at least about 60 weeks, at least about 68 weeks, at least about 72 weeks, at least about 80 weeks, at least about 88 weeks, at least about 96 weeks, and at least about 104 weeks. 
     
     
         40 . The method according to  claim 29 , wherein the individual is treated with cyclophosphamide prior to (c). 
     
     
         41 . The method according to  claim 29 , wherein the MUC-1 based formulation comprises about 300 μg of a MUC-1 peptide. 
     
     
         42 . The method according to  claim 29 , wherein the MUC-1 based formulation comprises about 1000 μg of a MUC-1 peptide.