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Summary for Patent: 8,092,828
|Title:||Fixed drug ratios for treatment of hematopoietic cancers and proliferative disorders|
|Abstract:||Provided herein are methods for treating cancer by administering a pharmaceutical composition comprising a fixed, non-antagonistic molar ratio of cytarabine and an anthracycline. Such methods are particularly useful in the treatment of patients with advanced hematologic cancers or proliferative disorders.|
|Inventor(s):||Louie; Arthur (Princeton, NJ), Swenson; Christine (Princeton Jct, NJ), Mayer; Lawrence (North Vancouver, CA), Janoff; Andrew (Yardley, PA)|
|Assignee:||Celator Pharmaceuticals, Inc. (Princeton, NJ)|
1. A method to treat a leukemia in a human patient, said method comprising administering intravenously to said patient a pharmaceutical composition comprising
cytarabine and daunorubicin at a fixed, molar ratio of cytarabine to daunorubicin of about 5:1 in an administration step of 8 hours or less, wherein said fixed ratio is maintained in the plasma for at least 4 hours, and wherein said fixed, molar ratio of
cytarabine and daunorubicin is encapsulated in liposomes; wherein the composition is administered to provide cytarabine in an amount of 32-134 mg/m.sup.2 and a total amount of 96-402 mg/m.sup.2 in a cycle of administration consisting of a first
administration step on day 1, a second administration step on day 3, and a third administration step on day 5; and wherein the liposomes comprise DSPC:DSPG:cholesterol at 7:2:1 molar ratio.
2. The method of claim 1 wherein the composition is administered in 3 hours or less for each administration step.
3. The method of claim 2, wherein the composition is administered in 90 minutes or less for each administration step.
4. The method of claim 1, wherein said administration is by intravenous (IV) drip.
5. The method of claim 1, wherein the leukemia is acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL).
6. The method of claim 1, wherein said subject has previously undergone at least one anti-cancer regimen, and/or has previously experienced a remission.
7. The method of claim 6 wherein said subject has experienced a relapse within 18 months after said anticancer regimen.
8. The method of claim 7 wherein said subject has experienced a relapse within 6 months after said anticancer regimen.
9. The method of claim 1, which further includes measuring a therapeutic effect as a function of increase in complete remission rate, and/or as a function of prolongation of complete remission duration and/or prolongation of time to progression and/or prolongation of survival.
10. The method of claim 1, which further includes measuring an improved safety result as a reduction in non-hematopoietic toxicities.
11. The method of claim 10, wherein the non-hematopoietic toxicities are mucositis and/or alopecia.
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