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Last Updated: March 28, 2024

Claims for Patent: 8,273,379


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Summary for Patent: 8,273,379
Title:Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
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.
Inventor(s): Warrell, Jr.; Raymond P. (Westfield, NJ), Pandolfi; Pier Paolo (New York, NY), Gabrilove; Janice L. (New York, NY)
Assignee: Memorial Sloan-Kettering Cancer Center (New York, NY)
Application Number:12/974,076
Patent Claims: 1. A method for treating a patient having a diagnosis of acute promyelocytic leukemia (APL) comprising administering to the patient a therapeutically effective amount of arsenic trioxide, wherein the diagnosis of APL in the patient involves assay for a t(15;17) chromosomal translocation or assay for expression of PML/RAR-.alpha..

2. The method of claim 1 wherein the assay for a t(15;17) chromosomal translocation is conducted using cytogenetics or fluorescence in situ hybridization (FISH).

3. The method of claim 1 wherein the expression of PML/RAR-.alpha. is assayed by reverse transcriptase polymerase chain reaction (RT-PCR).

4. The method of claim 1 wherein the therapeutically effective amount of arsenic trioxide is based on the body weight of the patient.

5. The method of claim 1 wherein the therapeutically effective amount of arsenic trioxide is about 0.001 to about 10.0 mg/kg body weight of the patient per day.

6. The method of claim 1 wherein the therapeutically effective amount of arsenic trioxide is about 0.05 to about 5.0 mg/kg body weight of the patient per day.

7. The method of claim 1 wherein the therapeutically effective amount of arsenic trioxide is about 0.01 to about 1.0 mg/kg body weight of the patient per day.

8. The method of claim 1 wherein the therapeutically effective amount of arsenic trioxide is about 0.15 mg of arsenic trioxide per kg of body weight of the patient per day.

9. The method of claim 1 wherein the arsenic trioxide is administered intravenously.

10. The method of claim 1 wherein the APL is refractory to conventional methods of treatment.

11. The method of claim 10 wherein the arsenic trioxide is administered to the patient in combination with all-trans retinoic acid (ATRA).

12. The method of claim 1 wherein the arsenic trioxide is administered to the patient in combination with another therapeutic agent.

13. The method of claim 12 wherein the arsenic trioxide is administered to the patient in combination with a chemotherapeutic agent.

14. The method of claim 12 wherein the arsenic trioxide is administered to the patient in combination with radiation treatment.

15. A method for treating a patient having a diagnosis of acute promyelocytic leukemia (APL) comprising administering to the patient a therapeutically effective amount of arsenic trioxide based on the body weight of the patient, wherein the diagnosis of APL in the patient involves assay for a t(15;17) chromosomal translocation or assay for expression of PML/RAR-.alpha..

16. The method of claim 15 wherein the assay for a t(15;17) chromosomal translocation is conducted using cytogenetics or fluorescence in situ hybridization (FISH) and expression of PML/RAR-.alpha. is assayed by reverse transcriptase polymerase (RT-PCR).

17. The method of claim 15 wherein the therapeutically effective amount of arsenic trioxide is about 0.15 mg of arsenic trioxide per kg of body weight of the patient per day.

18. The method of claim 15 wherein the arsenic trioxide is administered intravenously.

19. The method of claim 15 wherein the APL is refractory to conventional methods of treatment and the arsenic trioxide is administered to the patient in combination with all-trans retinoic acid (ATRA).

20. The method of claim 15 wherein the arsenic trioxide is administered to the patient in combination with a chemotherapeutic agent or radiation treatment.

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