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Claims for Patent: 5,496,804

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Claims for Patent: 5,496,804

Title: Method for treating taxol side-effects with G-CSF
Abstract:A method of treating a host using taxol comprising administering granulocyte colony-stimulating factor to the host being treated with taxol. The present inventive method allows for increased levels of taxol to be administered to the host in the treatment of various conditions, particularly with respect to ovarian tumors.
Inventor(s): Reed; Eddie (Germantown, MD), Kohn; Elise (Olney, MD), Sarosy; Gisele (Silver Spring, MD)
Assignee: The United States of America as represented by the Department of Health (Washington, DC)
Application Number:08/342,797
Patent Claims: 1. A method of treating a host being treated with taxol in an amount sufficient to cause a side effect selected from the group consisting of myelosupression, mucositis, and peripheral neuropathy, which method comprises administering to said host granulocyte colony-stimulating factor in an amount effective to alleviate or prevent said side effect.

2. The method of claim 1, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 / 21 days.

3. A method of claim 1, wherein said side effect is myelosuppression or mucositis.

4. The method of claim 3, wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 .mu.g/kg/day.

5. The method of claim 4, wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 .mu.g/kg/day.

6. The method of claim 1, wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment.

7. The method of claim 6 wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 / 21 days.

8. The method of claim 1, wherein said host is being treated with taxol to treat a cancerous tumor.

9. The method of claim 8, wherein said cancerous tumor is a breast, lung or ovarian tumor.

10. The method of claim 9, wherein said cancerous tumor is an ovarian tumor.

11. The method of claim 10, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 / 21 days.

12. The method of claim 11, wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 .mu.g/kg/day.

13. The method of claim 12, wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 .mu.g/kg/day.

14. The method of claim 13, wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment.

15. The method of claim 14, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 / 21 days.
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