IP Library Granted Patent US 10,172,839
Granted Patent B2
US 10,172,839 · App. 14/671,622 · Granted Jan 8, 2019

Use of short term starvation regimen in combination with kinase inhibitors to enhance traditional chemo-drug efficacy and feasibility and reverse side effects of kinases in normal cells and tissues

Inventors: Valter D. Longo (Playa del Rey, CA); Stefano Di Biase (Redondo Beach, CA)
Assignee: UNIVERSITY OF SOUTHERN CALIFORNIA
A61K31/436A61K31/475A61K31/4745A61K31/704
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Quick Facts
Patent No.
US 10,172,839
App. No.
14/671,622
Granted
Jan 8, 2019
Kind
B2
Abstract

A method of alleviating or treating symptoms of cancer and/or effects of chemotherapy or of kinase inhibitors includes a step of identifying a subject having cancer. A reduced caloric diet is administered to the subject for a first time period, the reduced caloric diet providing at most 1000 kcal per day. A kinase inhibitor is administered to the subject.

Claims (39)

1. A method for treating cancer, the method comprising:

a) identifying a subject having cancer;

b) administering a reduced caloric diet to the subject for a first time period, the reduced caloric diet providing at most 957 kcal per day, the reduced caloric diet providing:

on a first day less than 30 g of sugars, less than 28 g of plant based proteins, 20-30 grams of plant based monounsaturated fats, 6-10 g of plant based polyunsaturated fats and 2-12 g of plant based saturated fats; and

on days 2 to a final diet day less than 20 g of sugars, less than 18 g of plant based proteins, 10-15 g of plant based monounsaturated fats, 3-5 g of plant based polyunsaturated fats and 1-6 grams of plant based saturated fats, 10-30 grams of glycerol diluted in 1 liter of water/day, the reduced caloric diet being administered for a minimum length of 6 days and a maximum length of 21 days, the reduced caloric diet providing less than 20 g of protein per days; and

c) administering a kinase inhibitor to the subject to reduce tumor progression.

2. The method of claim 1 wherein steps b) and c) are repeated a plurality of times at predetermined intervals.

3. The method of claim 2 wherein steps b) and c) are repeated at intervals from two weeks to 2 months.

4. The method of claim 2 wherein the subject is administered a normal diet in between repetition of steps b) and c).

5. The method of claim 1 wherein the kinase inhibitor is administered during the first time period.

6. The method of claim 1 wherein the kinase inhibitor is administered after but within a week of the first time period.

7. The method of claim 1 further comprising administering a chemotherapeutic agent to the subject after the first time period.

8. The method of claim 7 wherein the reduced caloric diet is administered to the subject for a second time period after treatment with the chemotherapeutic agent commences.

9. The method of claim 7 wherein the chemotherapeutic agent is selected from the group consisting of topotecan, vincristine, doxorubicin, and combinations thereof.

10. The method of claim 8 wherein the second time period is from 1 to 3 days.

11. The method of claim 1 wherein the reduced caloric diet provides at most 500 kilocalories per day.

12. The method of claim 1 wherein carbohydrates provide less than half of the calories from the reduced caloric diet.

13. The method of claim 1 wherein the subject has melanoma or neuroblastoma or breast cancer.

14. The method of claim 1 wherein the kinase inhibitor is an mTOR protein kinase.

15. The method of claim 1 wherein a chance of survival for the subject is increased.

16. The method of claim 1 wherein the reduced caloric diet provides less than 5 g of protein per day.

17. The method of claim 1 wherein the reduced caloric diet provides at most 700 kcal per day.

18. A method for treating cancer and/or alleviating a symptom of chemotherapy, the method comprising:

a) identifying a subject having cancer;

b) administering a reduced caloric diet to the subject for a first time period, the reduced caloric diet providing at most 957 kcal per day, the reduced caloric diet providing:

on a first day less than 30 g of sugars, less than 28 g of plant based proteins, 20-30 grams of plant based monounsaturated fats, 6-10 g of plant based polyunsaturated fats and 2-12 g of plant based saturated fats; and

on days 2 to a final diet day less than 20 g of sugars, less than 18 g of plant based proteins, 10-15 g of plant based monounsaturated fats, 3-5 g of plant based polyunsaturated fats and 1-6 grams of plant based saturated fats, 10-30 grams of glycerol diluted in 1 liter of water/day, the reduced caloric diet being administered for a minimum length of 6 days and a maximum length of 21 days, the reduced caloric diet providing less than 20 g of protein per day;

c) administering a chemotherapeutic agent to the subject after the first time period; and

d) administering a kinase inhibitor to the subject, wherein the chemotherapeutic agent is different than the kinase inhibitor.

19. The method of claim 18 wherein steps b) and c) are repeated a plurality of times at predetermined intervals.

20. The method of claim 19 wherein steps b) and c) are repeated at intervals from two weeks to 2 months.

21. The method of claim 20 wherein the subject is administered a normal diet in between repetition of steps b) and c).

22. The method of claim 18 further comprising administering the reduced caloric diet to the subject for a second period of time after administering of the chemotherapeutic agent.

23. A method for alleviating a side effect of kinase inhibitor treatment, the method comprising:

a) identifying a subject being treated with a kinase inhibitor;

b) administering a kinase inhibitor to the subject; and

c) administering a reduced caloric diet to the subject for a first time period that is after the step of administering a kinase inhibitor, the reduced caloric diet providing at most 957 kcal per day and alleviating a side effect of kinase inhibitor treatment wherein the reduced caloric diet provides;

on a first day less than 30 g of sugars, less than 28 g of plant based proteins, 20-30 grams of plant based monounsaturated fats, 6-10 g of plat based polyunsaturated fats and 2-12 g of plant based saturated fats; and

on days 2 to a final diet day less than 20 g of sugars, less than 18 g of plant based proteins, 10-15 g of plant based monounsaturated fats, 3-5 g of plant based polyunsaturated fats and 1-6 grams of plant based saturated fats, 10-30 grams of glycerol diluted in 1 liter of water/day, the reduced caloric diet being administered for a minimum length of 6 days and a maximum length of 21 days.

Assignments (2)
CONFIRMATORY LICENSE Recorded May 13, 2015
From: UNIVERSITY OF SOUTHERN CALIFORNIA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 035655/0344 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2015
From: LONGO, VALTER D.; DI BIASE, STEFANO
To: UNIVERSITY OF SOUTHERN CALIFORNIA
Reel/Frame 035588/0007 →
Continuity (3)
Continuation PCTUS2015019102 · Mar 6, 2015
Provisional Application 61948792 · Mar 6, 2014
Related Publication 20150250771A1 · Sep 10, 2015
Cited By (3)
US 12,185,747 US 12,186,352 US 12,616,232