IP Library Granted Patent US 10,849,900
Granted Patent B2
US 10,849,900 · App. 15/114,058 · Granted Dec 1, 2020

Treatment of neoplasia

Inventors: David Cade (North Sydney, AU); Michael Tapner (North Sydney, AU)
Assignee: Sirtex Medical Limited
A61K31/519A61K31/282A61K31/513A61K31/555A61K39/3955A61K41/0038A61K45/06A61K51/1244A61N5/1001C07K16/22C07K16/30A61K2039/505A61K2039/545C07K2317/24
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Quick Facts
Patent No.
US 10,849,900
App. No.
15/114,058
Granted
Dec 1, 2020
Kind
B2
Abstract

A method of treating cancer in a patient comprising administering to the patient an a systemic chemotherapeutic drug regime in combination with radioactively doped particle, characterised in that the two therapies when introduced into the patient have an improved anticancer effect.

Claims (31)

1. A method for treatment of a cancer patient in need of treatment, which comprises the steps of:

(i) delivering to said patient a treatment that lowers toxicity resulting from combining a radio-sensitizing agent oxaliplatin (OXA) with selective internal radiation therapy (SIRT), comprising on day one of a first chemotherapy treatment regime, comprising:

(a) a 2-hour infusion of oxaliplatin (OXA) at a dose of about 60 to 80 mg/m 2 ;

(b) a 2-hour infusion of leucovorin (LV) at a dose of about 100 to 400 mg/m 2 ;

(c) followed by a bolus of 5-fluorouracil (5-FU) at a dose of about 300 to 500 mg/m 2 and then an infusion of 5-FU for about 40 to 50 hours at a dose of about 2.0 to 2.6 g/m 2 ; and repeating step (i), if required, then

(ii) delivering selective internal radiation therapy (SIRT) to said patient between days 3 to 14 following either the commencement of step (i) or following the repeat of step (i);

(iii) repeating step (i) for three cycles at an interval of one to three weeks between treatment cycles; then

(iv) two weeks after the final treatment delivered in step (iii) delivering to said patient a second chemotherapy treatment regime, comprising:

(a) a 2-hour infusion of OXA at a dose of about 85 to 100 mg/m 2 ;

(b) a 2-hour infusion of LV at a dose of about 100 and 400 mg/m 2 ;

(c) followed by a bolus of 5-FU at a dose of about 300 to 500 mg/m 2 and then an infusion of 5-FU for about 40 to 50 hours at a dose of about 2.0 to 2.6 g/m 2 .

2. A method according to claim 1 further comprising the step of repeating step (iv) every 2 to 3 weeks, until the cancer is treated.

3. A method according to claim 1 , wherein the dose of OXA used in step (i)(a) is selected from one of the following OXA doses: 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80 mg/m 2 .

4. A method according to claim 1 , wherein the dose of OXA used in step (iv)(a) is selected from one of the following OXA doses: 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 mg/m 2 .

5. A method according to claim 1 , wherein the dose of LV used in step (i)(b) or (iv)(b) is selected from one of the following LV doses: 100, 110, 120, 130, 140, 150, 160, 170, 180 and 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400 mg/m 2 .

6. A method according to claim 1 , wherein the bolus dose of 5-FU used in step (i)(c) or (iv)(c) is selected from one of the following 5-FU doses: 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500 mg/m 2 .

7. A method according to claim 1 , wherein the infusion dose of 5-FU used in step (i)(c) or (iv)(c) is selected from one of the following 5-FU doses: 2.1, 2.2, 2.3, 2.4 and 2.5 g/m 2 .

8. A method according to claim 1 , comprising the step of treating the patient with bevacizumab.

9. A method according to claim 8 wherein bevacizumab is administered at a dose of about 5 to 10 mg/kg.

10. A method according to claim 9 wherein the bevacizumab is delivered to a patient in 30 to 60 minutes.

11. A method according to claim 8 wherein the bevacizumab therapy is delivered to said patient in the last cycle of therapy immediately after OXA therapy.

12. A method according to claim 1 , wherein one or more chemotherapeutic agents additional to those used in the method are incorporated into systemic chemotherapy procedure drugs.

13. A method according claim 12 wherein the chemotherapeutic agents are selected from irinotecan or capecitabine.

14. A method according to claim 1 , wherein the patient is also treated with an anti-angiogenesis factor.

15. A method according to claim 1 , wherein the patient receives an amount of SIRT therapy suitable to effectively treat a cancer.

16. A method according to claim 1 , wherein the SIRT therapy is administered using SIR-Spheres™ microspheres.

17. A method according claim 16 wherein the prescribed activity of the SIR-Spheres™ microspheres in both lobes of the liver is between 1.2 and 2.4 GBq.

18. The method according to claim 1 , wherein step (iv) comprises two weeks after the final treatment is delivered in step (iii) a second chemotherapy treatment regime is delivered to said patient, wherein said second chemotherapy treatment regime comprises:

(a) a 2-hour infusion of OXA at a dose of about 85 to 100 mg/m 2 ;

(b) a 2-hour infusion of LV at a dose of about 100 and 400 mg/m 2 ;

(c) followed by a bolus of 5-FU at a dose of about 300 to 500 mg/m 2 and a 15 to 90 minute infusion of bevacizumab at about 5 to 15 mg/kg, followed by an infusion of 5-FU for about 40 to 50 hours at a dose of about 2.0 to 2.6 g/m 2 .

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Jun 27, 2024
From: CHINA CITIC BANK INTERNATIONAL LIMITED
To: GRAND PHARMA SPHERE (AUSTRALIA BIDCO) PTY LTD; SIRTEX MEDICAL PTY LTD; SIRTEX MEDICAL PRODUCTS PTY LTD; SIRTEX GLOBAL PTY LTD; SIRTEX TECHNOLOGY PTY LTD
Reel/Frame 067944/0310 →
SECURITY INTEREST Recorded Jun 16, 2022
From: GRAND PHARMA SPHERE (AUSTRALIA BIDCO) PTY LTD; SIRTEX MEDICAL PTY LTD; SIRTEX MEDICAL PRODUCTS PTY LTD; SIRTEX GLOBAL PTY LTD; SIRTEX TECHNOLOGY PTY LTD
To: CHINA CITIC BANK INTERNATIONAL LIMITED
Reel/Frame 060450/0744 →
SECURITY INTEREST Recorded Nov 30, 2018
From: SIRTEX MEDICAL LIMITED
To: BANK OF CHINA LIMITED MACAU BRANCH
Reel/Frame 047691/0520 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2016
From: CADE, DAVID; TAPNER, MICHAEL
To: SIRTEX MEDICAL LIMITED
Reel/Frame 040272/0248 →
Priority Claims (1)
AU 2014900232 · Jan 24, 2014 · national
Continuity (1)
Related Publication 20170000795A1 · Jan 5, 2017