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 . (canceled) 
     
     
         2 . A method for treating an individual with prostate cancer comprising:
 a. selecting for treatment an individual who has prostate cancer, and   b. administering to that individual, for a period of time, a MUC-1-based formulation, wherein said formulation comprises a liposome comprising at least one polypeptide comprising a lipidated MUC-1 amino acid sequence selected from the group consisting of the amino acid sequence of SEQ ID NOs: 1 or 2.   
     
     
         3 . The method of  claim 2 , wherein the MUC-1-based formulation further comprises at least one adjuvant, wherein optionally:
 a. the adjuvant is a lipid A, or wherein   b. the adjuvant is a muramyl dipeptide, or wherein   c. the adjuvant is a cytokine.   
     
     
         4 . (canceled) 
     
     
         5 . The method of  claim 3 , wherein the adjuvant is monophosphoryl lipid A or interleukin-2. 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 2 , wherein the treated individual has prostate cancer with rising PSA following radical prostatectomy. 
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 2 , wherein the MUC-1-based formulation further comprises one or more additional liposomal lipids. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 2 , wherein the MUC-1-based formulation is administered by injection, aerosol, nasal delivery, or oral delivery, and wherein the injection is an intramuscular injection, a subcutaneous injection, or an intradermal injection. 
     
     
         16 . The method of  claim 2 , wherein the MUC-1-based formulation is administered for a period of time selected from the group consisting of for 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, at least 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, or at least about 104 weeks. 
     
     
         17 . The method of  claim 2 , wherein the individual is treated with the MUC-1-based formulation in combination with a pre-treatment with cyclophosphamide. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 2 , wherein the MUC-1-based formulation for use in improving or maintaining the quality of life of the individual diagnosed with prostate cancer, wherein such effect on the quality of life is ascertainable from a combined score of the individual's physical well-being, functional well-being, and prostate cancer symptoms before, and after the period of time wherein the individual had been diagnosed with prostate cancer. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 3 , wherein
 a. the amount of MUC-1 peptide is about 300 μg, or wherein   b. the amount of MUC-1 peptide is about 800 μg to about 1200 μg, or wherein   c. the amount of MUC-1 peptide is about 900 μg.   
     
     
         24 . The method of  claim 3 , wherein the adjuvant is lipid A. 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . The method of  claim 2 , wherein the polypeptide comprises an amino acid sequence of SEQ ID NO: 1. 
     
     
         28 . The method of  claim 2 , wherein the polypeptide comprises an amino acid sequence of SEQ ID NO: 2. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled)