Methods of using (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4- oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid for treatment of cancer
View Patent ↗Methods of treating, preventing or managing cancer, including certain leukemias are disclosed. The methods encompass the administration of enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid. Also provided are methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods are also disclosed.
1. A method of treating acute myelogenous leukemia comprising administering a dose of 50 to 90 mg/m 2 of an enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid to a human with acute myelogenous leukemia.
2. The method of claim 1 , wherein the acute myelogenous leukemia is a myeloblastic leukemia or promyelocytic leukemia.
3. The method of claim 1 , wherein the leukemia is relapsed, refractory or resistant to therapy selected from surgery, chemotherapy, radiation therapy, hormonal therapy, biological therapy, immunotherapy, blood transfusions, and combinations thereof.
4. The method of claim 1 , wherein the dose is from 50 mg/m 2 to 80 mg/m 2 administered once a week for at least two weeks.
5. The method of claim 4 , wherein the dose is from 55 mg/m 2 to 75 mg/m 2 .
6. The method of claim 5 , wherein the dose is 60 mg/m 2 .
7. The method of claim 5 , wherein the dose is 65 mg/m 2 .
8. The method of claim 5 , wherein the dose is 70 mg/m 2 .
9. The method of claim 5 , wherein the dose is 75 mg/m 2 .
10. The method of claim 1 , wherein the dose is administered once a week for three weeks.
11. The method of claim 1 , wherein the dose is administered twice a week.
12. The method of claim 11 , wherein the dose is from 80 mg/m 2 to 90 mg/m 2 .
13. The method of claim 11 , wherein the dose is 65 mg/m 2 to 75 mg/m 2 .
14. The method of claim 11 , wherein the dose is administered for two weeks.
15. The method of claim 1 , wherein the enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid is administered as an IV injection.
16. The method of claim 1 , wherein the dose is administered in an IV push of 10-15 minutes duration.
17. A method of treating acute myelogenous leukemia comprising administering a dose of 85 to 95 mg/m 2 of an enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid to a human with acute myelogenous leukemia.
18. A method of treating acute myelogenous leukemia comprising administering a dose of 90 to 100 mg/m 2 of an enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid to a human with acute myelogenous leukemia.
19. The method of claim 17 or 18 , wherein the acute myelogenous leukemia is a myeloblastic leukemia or promyelocytic leukemia.
20. The method of claim 17 or 18 , wherein the leukemia is relapsed, refractory or resistant to therapy selected from surgery, chemotherapy, radiation therapy, hormonal therapy, biological therapy, immunotherapy, blood transfusions, and combinations thereof.
21. The method of claim 17 or 18 , wherein the dose is administered once a week for three weeks.
22. The method of claim 17 or 18 , wherein the dose is administered twice a week.
23. The method of claim 17 or 18 , wherein the enantiomerically pure (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid is administered as an IV injection.
24. The method of claim 17 or 18 , wherein the dose is administered in an IV push of 10-15 minutes duration.