Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol

• US 20040146574A1
• Filed: 01/16/2004
• Published: 07/29/2004
• Est. Priority Date: 11/10/1997
• Status: Active Grant

• Current Assignee: Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
• Original Assignee: Memorial Sloan-Kettering Cancer Center
• Inventors: Gabrilove, Janice L., Pandolfi, Pier Paolo, Warrell, Raymond P. Jr.
• Granted Patent: US 6,884,439 B2
• Time in Patent Office: Days
• US Class Current: 424/623
• 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 31/285 Arsenic compounds
• CPC Class Codes: A61K 31/53 having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 33/24 Heavy metals; Compounds thereof
• CPC Class Codes: A61K 33/36 Arsenic; Compounds thereof
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to the use of arsenic compounds to treat a variety of leukemia, lymphoma and solid tumors. Further, the arsenic compounds may be used in combination with other therapeutic agents, such as a retinoid. The invention also provides a process for producing arsenic trioxide formulations.

Claims

1. A method for treating acute promyelogenous leukemia in a human comprising administering a therapeutically effective dosage amount of about 0.15 mg/kg arsenic trioxide once per day.

2. The method of claim 1, wherein said arsenic trioxide is administered until bone marrow remission, which constitutes a first administration.

3. The method of claim 2, further comprising a second administration of a therapeutically effective dosage amount of about 0.15 mg/kg arsenic trioxide once per day for 25 doses.

4. The method of claim 3, wherein said second administration is administered 3 to 6 weeks after said first administration.

5. The method of claim 4, wherein said second administration is administered for up to five weeks.

6. The method of claim 5, wherein said second administration is administered at five doses per week.

7. The method of claim 3, further comprising repeating said second administration.

8. The method of claim 7, wherein said second administration is repeated every 3 to 6 weeks.

9. The method of claim 8, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

10. The method of claim 9, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

11. The method of claim 9, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

12. The method of claim 1, wherein said arsenic trioxide is administered for up to sixty days, which constitutes a first administration.

13. The method of claim 12, further comprising a second administration of a therapeutically effective dosage amount of about 0.15 mg/kg arsenic trioxide once per day for 25 doses.

14. The method of claim 13, wherein said second administration is administered 3 to 6 weeks after said first administration.

15. The method of claim 14, wherein said second administration is administered for up to five weeks.

16. The method of claim 15, wherein said second administration is administered at five doses per week.

17. The method of claim 13, further comprising repeating said second administration.

18. The method of claim 17, wherein said second administration is repeated every 3 to 6 weeks.

19. The method of claim 18, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

20. The method of claim 19, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

21. The method of claim 19, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.