Methods of treating cancer with high potency lipid-based platinum compound formulations administered intravenously

• US 20070190180A1
• Filed: 11/03/2006
• Published: 08/16/2007
• Est. Priority Date: 11/08/2005
• Status: Abandoned Application

• Current Assignee: Frank Pilkiewicz, Jin Lee, Mary Neville, Roman Perez-Soler, Walter Perkins, Yiyu Zou
• Original Assignee: Frank Pilkiewicz, Jin Lee, Mary Neville, Roman Perez-Soler, Walter Perkins, Yiyu Zou
• Inventors: Lee, Jin, Zou, Yiyu, Perez-Soler, Roman, Neville, Mary, Perkins, Walter, Pilkiewicz, Frank
• Application Number:
  US11/592,714
• Publication Number:
  US 20070190180A1
• Time in Patent Office: Days
• US Class Current: 424/649
• CPC Class Codes: A61K 31/282 Platinum compounds
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/127 Liposomes

Abstract

In one aspect, the present invention relates to methods of treating cancer in a patient comprising administering intravenously to a patient in need thereof a cancer treating effective amount of a lipid-based platinum compound formulation wherein the concentration of the platinum compound of the lipid-based platinum compound formulation is greater than about 1.2 mg/ml.

Claims

1. A method of treating cancer in a patient comprising administering intravenously to a patient in need thereof a cancer treating effective amount of a lipid-based platinum compound formulation wherein the concentration of the platinum compound of the lipid-based platinum compound formulation is greater than about 1.2 mg/ml.

2. The method of claim 1, wherein the platinum compound concentration is about 3 mg/ml.

3. The method of claim 1, wherein the platinum compound concentration is about 5 mg/ml.

4. The method of claim 1, wherein the platinum compound is selected from the group consisting of:

cisplatin, carboplatin (diammine(1,1-cyclobutanedicarboxylato)-platinum(II)), tetraplatin (ormaplatin) (tetrachloro(1,2-cyclohexanediamine-N,N′

)-platinum(IV)), thioplatin (bis(O-ethyldithiocarbonato)platinum(II)), satraplatin, nedaplatin, oxaliplatin, heptaplatin, iproplatin, transplatin, lobaplatin, cis-aminedichloro(2-methylpyridine) platinum, JM118 (cis-amminedichloro (cyclohexylamine)platinum(II)), JM149 (cis-amminedichloro(cyclohexylamine)-trans-dihydroxoplatinum(IV)), JM216 (bis-acetato-cis-amminedichloro(cyclohexylamine) platinum(IV)), JM335 (trans-amminedichloro (cyclohexylamine)dihydroxoplatinum(IV)), (trans, trans, trans)bis-mu-(hexane-1,6-diamine)-mu-[diamine-platinum(II)]bis[diamine(chloro) platinum(II)]tetrachloride, and mixture thereof.

5. The method of claim 1, wherein the platinum compound is cisplatin.

6. The method of claim 1, wherein the lipid in the lipid-based platinum compound formulation is comprised of a member selected from the group consisting of:

egg phosphatidylcholine (EPC), egg phosphatidylglycerol (EPG), egg phosphatidylinositol (EPI), egg phosphatidylserine (EPS), phosphatidylethanolamine (EPE), phosphatidic acid (EPA), soy phosphatidyl choline (SPC), soy phosphatidylglycerol (SPG), soy phosphatidylserine (SPS), soy phosphatidylinositol (SPI), soy phosphatidylethanolamine (SPE), soy phosphatidic acid (SPA), hydrogenated egg phosphatidyl choline (HEPC), hydrogenated egg phosphatidylglycerol (HEPG), hydrogenated egg phosphatidylinositol (HEPI), hydrogenated egg phosphatidylserine (HEPS), hydrogenated phosphatidylethanolamine (HEPE), hydrogenated phosphatidic acid (HEPA), hydrogenated soy phosphatidylcholine (HSPC), hydrogenated soy phosphatidylglycerol (HSPG), hydrogenated soy phosphatidylserine (HSPS), hydrogenated soy phosphatidylinositol (HSPI), hydrogenated soy phosphatidylethanolamine (HSPE), hydrogenated soy phosphatidic acid (HSPA), dipalmitoylphosphatidylcholine (DPPC), dimyristoylphosphatidylcholine (DMPC), dimyristoylphosphatidylglycerol (DMPG), dipalmitoylphosphatidylglycerol (DPPG), distearoylphosphatidylcholine (DSPC), distearoylphosphatidylglycerol (DSPG), dioleylphosphatidyl-ethanolamine (DOPE), palmitoylstearoylphosphatidyl-choline (PSPC), palmitoylstearolphosphatidylglycerol (PSPG), mono-oleoyl-phosphatidylethanolamine (MOPE), cholesterol, ergosterol, lanosterol, tocopherol, ammonium salts of fatty acids, ammonium salts of phospholids, ammonium salts of glycerides, myristylamine, palmitylamine, laurylamine, stearylamine, dilauroyl ethylphosphocholine (DLEP), dimyristoyl ethylphosphocholine (DMEP), dipalmitoyl ethylphosphocholine (DPEP) and distearoyl ethylphosphocholine (DSEP), N-(2,3-di-(9-(Z)-octadecenyloxy)-prop-1-yl-N,N,N-trimethylammonium chloride (DOTMA), 1,2-bis(oleoyloxy)-3-(trimethylammonio)propane (DOTAP), phosphatidyl-glycerols (PGs), phosphatidic acids (PAs), phosphatidylinositols (PIs), phosphatidyl serines (PSs), distearoylphosphatidylglycerol (DSPG), dimyristoylphosphatidylacid (DMPA), dipalmitoylphosphatidylacid (DPPA), distearoylphosphatidylacid (DSPA), dimyristoylphosphatidylinositol (DMPI), dipalmitoylphosphatidylinositol (DPPI), distearoylphospatidylinositol (DSPI), dimyristoylphosphatidylserine (DMPS), dipalmitoylphosphatidylserine (DPPS), distearoylphosphatidylserine (DSPS), and mixture thereof.

7. The method of claim 1, wherein the lipid in the lipid-based platinum compound formulation is a mixture of a phospholipid and a sterol.

8. The method of claim 1, wherein the lipid in the lipid-based platinum compound formulation is a mixture of DPPC and cholesterol.

9. The method of claim 1, wherein the lipid in the lipid-based platinum compound formulation is a mixture of DPPC from 50 to 65 mol % and cholesterol from 35 to 50 mol %.

10. The method of claim 1, wherein the cancer is selected from the following:

melanoma, testis (germ cell), osteosarcoma, soft tissue sarcoma, thyroid cancer, colon cancer, ovarian cancer, cancer of the kidney, breast cancer, colorectal cancer, prostate cancer, bladder cancer, uterine cancer, lung cancer, stomach cancer, liver cancer, spleen cancer, endometrial, or squamous cell carcinomas of the head and neck.

11. The method of claim 1, wherein the cancer is lung cancer.

12. The method of claim 1, wherein the cancer is spleen cancer.

13. The method of claim 1, wherein the cancer is liver cancer.

14. The method of claim 1, wherein the ratio of platinum compound to lipid in the lipid-based platinum compound formulation is between 1:

5 by weight and 1;

50 by weight.

15. The method of claim 1, wherein the lipid-based platinum compound formulation comprises liposomes having a mean diameter of 0.01 microns to 3.0 microns.

16. The method of claim 1, wherein the lipid is a mixture of DPPC and cholesterol, the ratio of platinum compound to lipid in the lipid-based platinum compound formulation is between 1:

5 by weight and 1;

50 by weight, and wherein the lipid-based platinum compound formulation comprises liposomes having a mean diameter of 0.01 microns to 3.0 microns.

17. The method of claim 1, wherein the lipid is a mixture of DPPC and cholesterol, the ratio of platinum compound to lipid in the lipid-based platinum compound formulation is between 1:

5 by weight and 1;

50 by weight, the lipid-based platinum compound formulation comprises liposomes having a mean diameter of 0.01 microns to 3.0 microns, and wherein the platinum compound is cisplatin.

18. The method of claim 1, wherein the lipid is a mixture of DPPC and cholesterol in a 2 to I ratio by weight, the ratio of platinum compound to lipid in the lipid-based platinum compound formulation is about 1:

20 by weight, the lipid-based platinum compound formulation comprises liposomes having a mean diameter of about 0.40 microns, and wherein the platinum compound is cisplatin.

19. The method of claim 1, wherein the patient is a human.

20. The method of claim 1, wherein the lipid-based platinum compound formulation is administered to the patient at least once every three weeks.

21. The method of claim 1, wherein the amount of platinum compound in the lipid-based platinum compound formulation is 60 mg/m² or greater, 100 mg/m² or greater, 140 mg/m² or greater, or 180 mg/m² or greater.

22. The method of claim 1, wherein the amount of platinum compound in the lipid-based platinum compound formulation is 100 mg/m² or greater, and the lipid-based platinum compound formulation is administered to the patient at least once every three weeks.