Method of preventing and treating chemotherapy-induced alopecia

• US 5,486,509 A
• Filed: 05/27/1994
• Issued: 01/23/1996
• Est. Priority Date: 06/28/1991
• Status: Expired due to Fees

• Current Assignee: University of Miami
• Original Assignee: University of Miami
• Inventors: Jimenez, Joaquin J., Yunis, Adel A.
• Primary Examiner(s): Walsh, Stephen G.
• Assistant Examiner(s): SPECTOR, LORRAINE
• Application Number:
  US08/250,646
• Time in Patent Office: 606 Days
• Field of Search: 424/45, 514/711, 514/12, 514/21, 514/167-171, 530/399, 552/653
• US Class Current: 514/167
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/67 Vitamins
• CPC Class Codes: A61Q 7/00 Preparations for affecting hair growth
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

The present invention relates, in general, to a method of inhibiting alopecia, or hair loss, and, in particular, to a method of inhibiting alopecia induced by chemotherapeutic agents. The invention further relates to a composition suitable for use in such a method. Active agents for use in the above method include proteinaceous growth factors, such as EGF, and/or vitamin D₃ or metabolites thereof.

Claims

1. A method of reducing chemotherapy-induced alopecia comprising administering to a host treated with at least one chemotherapeutic agent which induces such alopecia an effective amount of vitamin D₃ or derivative or analog or active metabolite thereof.

2. The method according to claim 1 wherein said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol.

3. The method according to claim 1 wherein said vitamin D₃, derivative analog or active metabolite thereof is administered topically.

4. The method according to claim 1 wherein said at least one chemotherapeutic agent is cell cycle specific.

5. The method according to claim 4 wherein said at least one chemotherapeutic agent is cytosine arabinoside.

6. The method according to claim 1 wherein said at least one chemotherapeutic agent is non-cell cycle specific.

7. The method according to claim 6 wherein said at least one chemotherapeutic agent is Cytoxan.

8. The method according to claim 1 wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent.

9. The method according to claim 1 wherein vitamin D₃, or derivative or analog or active metabolite thereof, is administered prior to the initiation of said chemotherapy.

10. The method according to claim 1, wherein the vitamin D₃, derivative or analog or active metabolite thereof is administered by topically applying the same to the host prior to administering said chemotherapy.

11. The method according to claim 1 wherein said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol and is administered topically.

12. The method according to claim 1 wherein said at least one chemotherapeutic agent is cell cycle specific and said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol.

13. The method according to claim 1, wherein said at least one chemotherapeutic agent is cell cycle specific and said vitamin D₃ or derivative, analog or active metabolite thereof is administered topically.

14. The method according to claim 1, wherein said at least one chemotherapeutic agent is cell cycle specific and comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1, 25-dihydroxyvitamin D₃.

15. The method according to claim 1 wherein said at least one chemotherapeutic agent is non cell cycle specific and said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol.

16. The method according to claim 1 wherein said at least one chemotherapeutic agent is non cell cycle specific and said vitamin D₃ or derivative, analog or active metabolite thereof is administered topically.

17. The method according to claim 1 wherein said at least one chemotherapeutic agent is non cell cycle specific and comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1, 25-dihydroxyvitamin D₃.

18. The method according to claim 1 wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent and said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol.

19. The method according to claim 1 wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent and said vitamin D₃ or derivative, analog or active metabolite thereof is administered topically.

20. The method according to claim 1 wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent and comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1, 25-dihydroxyvitamin D₃.

21. The method according to claim 1, wherein the vitamin D₃, or derivative or analog or active metabolite thereof is administered by topically applying the same to the host prior to administering said chemotherapy and said derivative, analog or active metabolite is selected from the group consisting of 1,25-dihydroxyvitamin D₃ and 1,25-dihydroxy-16-ene-23-yne-cholecalciferol.

22. The method according to claim 1, wherein the vitamin D₃, or derivative or analog or active metabolite thereof is administered by topically applying the same to the host prior to administering said chemotherapy and comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1, 25-dihydroxyvitamin D₃.

23. The method according to claim 1 comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃.

24. The method according to claim 1, comprising topically administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃.

25. The method according to claim 1, comprising topically administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃ and wherein said chemotherapeutic agent is cell cycle specific.

26. The method according to claim 1, comprising topically administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃ and wherein said at least one chemotherapeutic agent is non cell cycle specific.

27. The method according to claim 1, comprising topically administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃ and wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent.

28. The method according to claim 1, comprising administering vitamin D₃, 1,25-dihydroxy-16-ene-23-yne-cholecalciferol, 1α

-hydroxyvitamin D₃, 1α

, 24-dihydroxyvitamin D₃ or 1,25-dihydroxyvitamin D₃ prior to the initiation of said chemotherapy.

29. A method of reducing chemotherapy-induced alopecia comprising administering to a patient undergoing chemotherapy with at least one chemotherapeutic agent 1,25-dihydroxyvitamin D₃ in an effective amount.

30. The method according to claim 29 wherein said 1,25-dihydroxyvitamin D₃ is administered topically.

31. The method according to claim 29 wherein said at least one chemotherapeutic agent is cell cycle specific.

32. The method according to claim 31 wherein said at least one chemotherapeutic agent is cytosine arabinoside.

33. The method according to claim 29 wherein said at least one chemotherapeutic agent is non cell cycle specific.

34. The method according to claim 33 wherein said at least one chemotherapeutic agent is Cytoxan.

35. The method according to claim 31 wherein said at least one chemotherapeutic agent is a cell cycle specific agent in combination with a non cell cycle specific agent.

36. The method according to claim 31 wherein the 1,25-dihydroxyvitamin D₃ is administered prior to the initiation of said chemotherapy.

37. The method according to claim 31, wherein the 1,25-dihydroxyvitamin D₃ is administered by topical application to the host prior to administering said chemotherapy.