Pharmaceutical compositions and methods

1. A method of treating breast cancer in a subject comprising administering an effective amount of a tyrosine hydroxylase inhibitor; a melanin promoter; a p450 3A4 promoter; and a leucine aminopeptidase inhibitor to the subject in need thereof, wherein:

the melanin promoter is methoxsalen or melanotan II;

the p450 3A4 promoter is 5,5-diphenylhydantoin, valproic acid, or carbamazepine; and

the leucine aminopeptidase inhibitor is N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine or rapamycin.

2. The method of claim 1 further comprising administering a growth hormone inhibitor.

3. The method of claim 1 wherein at least two of the promoters and inhibitors are administered simultaneously.

4. The method of claim 1 wherein at least three of the promoters and inhibitors are administered simultaneously.

5. The method of claim 1 wherein each of the promoters and inhibitors is administered simultaneously.

6. The method of claim 1 wherein the promoters and inhibitors are administered orally, subcutaneously, intravenously, transdermally, vaginally, rectally or in any combination thereof.

7. The method of claim 6 wherein the transdermal administration is done with oleic acid, 1-methyl-2-pyrrolidone, or dodecylnonaoxyethylene glycol monoether.

8. The method of claim 1 wherein the promoters and inhibitors are administered during a cycle consisting of five to seven days of administering the promoters and inhibitors and one to two days of not administering the promoters and inhibitors.

9. The method of claim 8 wherein the promoters and inhibitors are administered over the course of at least six of said cycles.

10. The method of claim 1 wherein the tyrosine hydroxylase inhibitor is a tyrosine derivative.

11. The method of claim 10 wherein the tyrosine derivative is one or more of methyl (2R)-2-amino-3-(2-chloro-4 hydroxyphenyl)propanoate, D-tyrosine ethyl ester hydrochloride, methyl (2R)-2-amino-3-(2,6-dichloro-3,4-dimethoxyphenyl)propanoate H-D-Tyr(TBU)-allyl ester HCl, methyl (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl)propanoate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl)propanoate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl)propanoate, methyl (2R)-2-amino-3-(2-chloro-3,4-dimethoxyphenyl)propanoate, methyl (2R)-2-amino-3-(3-chloro-5-fluoro-4-hydroxyphenyl)propanoate, diethyl 2-(acetylamino)-2-(4-[(2-chloro-6-fluorobenzyl)oxy]benzyl malonate, methyl (2R)-2-amino-3-(3-chloro-4-methoxyphenyl)propanoate, methyl (2R)-2-amino-3-(3-chloro-4-hydroxy-5-methoxyphenyl)propanoate, methyl (2R)-2-amino-3-(2,6-dichloro-3-hydroxy-4-methoxyphenyl)propanoate, methyl (2R)-2-amino-3-(3-chloro-4-hydroxyphenyl)propanoate, H-DL-tyr-OME HCl, H-3,5-diiodo-tyr-OME HCl, H-D-3,5-diiodo-tyr-OME HCl, H-D-tyr-OME HCl, D-tyrosine methyl ester hydrochloride, D-tyrosine-ome HCl, methyl D-tyrosinate hydrochloride, HD-tyr-OMe.HCl, D-tyrosine methyl ester HCl, H-D-Tyr-OMe-HCl, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid, (2R)-2-amino-3-(4-hydroxyphenyl)methyl ester hydrochloride, methyl (2R)-2-amino-3-(4-hydroxyphenyl)propanoate hydrochloride, methyl (2R)-2-azanyl-3-(4-hydroxyphenyl)propanoate hydrochloride, 3-chloro-L-tyrosine, 3-nitro-L-tyrosine, 3-nitro-L-tyrosine ethyl ester hydrochloride, DL-m-tyrosine, DL-o-tyrosine, Boc-Tyr (3,5-I2)-OSu, Fmoc-tyr(3-NO2)-OH, and α-methyl-DL-tyrosine.

12. The method of claim 11 wherein 60 mg of the tyrosine derivative is administered orally and 0.25 mL of a 2 mg/mL suspension of the tyrosine derivative is administered subcutaneously.

13. The method of claim 1 wherein the melanin promoter is methoxsalen.

14. The method of claim 13 wherein 10 mg of the methoxsalen is administered orally and 0.25 mL of a 1 mg/mL suspension of the methoxsalen is administered subcutaneously.

15. The method of claim 1 wherein the melanin promoter is melanotan II.

16. The method of claim 1 wherein the p450 3A4 promoter is 5,5-diphenylhydantoin.

17. The method of claim 16 wherein 30 mg of the 5,5-diphenylhydantoin is administered orally.

18. The method of claim 1 wherein the p450 3A4 promoter is valproic acid or carbamazepine.

19. The method of claim 1 wherein the leucine aminopeptidase inhibitor is N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine.

20. The method of claim 19 wherein 20 mg of the N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine is administered orally.

21. The method of claim 1 wherein the leucine aminopeptidase inhibitor is rapamycin.

22. The method of claim 19 wherein the p450 3A4 promoter is 5,5-diphenylhydantoin.

23. The method of claim 22 wherein the melanin promoter is melanotan II.

24. The method of claim 1 further comprising administering an effective amount of D-leucine.

25. The method of claim 23 wherein the tyrosine derivative is α-methyl-DL tyrosine.

26. The method of claim 1 wherein the melanin promoter is melanotan II; the p450 3A4 promoter is 5,5-diphenylhydantoin; and the tyrosine hydroxylase inhibitor is α-methyl-DL tyrosine.

27. The method of claim 26 wherein the leucine aminopeptidase inhibitor is N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine.

28. The method of claim 26 wherein the leucine aminopeptidase inhibitor is rapamycin.

29. The method of claim 1 further comprising assessing progression of said cancer in said subject.

30. The method of claim 2 further comprising assessing progression of said cancer in said subject.