RADIATION SENSITIZER OR ANTI-CANCER CHEMOTHERAPY SENSITIZER

Abstract

The present invention provides a novel radiosensitizer or anti-cancer chemotherapy sensitizer. In particular, the invention provides a radiosensitizer or anti-cancer chemotherapy sensitizer that can relieve the irritation of an affected area caused by hydrogen peroxide, is safe when injected into a human body, and can delay or reduce the degradation of hydrogen peroxide and thereby can efficiently exert a radiation sensitizing effect and an anti-cancer chemotherapy sensitizing effect. The radiosensitizer or anti-cancer chemotherapy sensitizer comprises a combination of (a) hydrogen peroxide and (b) hyaluronic acid or salt thereof.

Claims

1-21. (canceled)

22. A method of treating cancer in a patient comprising: (1) a step of applying to a tumor a composition comprising (a) 0.01 to 3.5 weight percent of hydrogen peroxide in a final formulation and (b) a gelatin, wherein applying the composition is an intratumoral injection, and (2) a step of performing a radiotherapy treatment or an anti-cancer chemotherapy treatment at the same time as or after the step (1), wherein the composition delays or reduces degradation of the hydrogen peroxide in the tumor and reduces irritation of the hydrogen peroxide at the time of the injection.

23. The method of treating cancer according to claim 22, wherein the tumor is resistant to the radiotherapy treatment or resistant to the anti-cancer chemotherapy treatment.

24. The method of treating cancer according to claim 22, wherein the radiotherapy treatment is performed and comprises irradiation with an X-ray beam or electron beam from a linear accelerator.

25. The method of treating cancer according to claim 22, wherein the anti-cancer chemotherapy treatment is performed and comprises administering an anti-cancer agent to the patient.

26. The method of treating cancer according to claim 22, wherein a content of the gelatin in a final formulation of the composition is 0.1 to 10 weight percent.

27. The method according to claim 22, wherein the concentration of the hydrogen peroxide in the final formulation is 0.1 to 2 weight percent.

28. The method according to claim 22, wherein the concentration of the hydrogen peroxide in the final formulation is 0.36 to 2 weight percent.

29. The method according to claim 22, wherein the intratumoral injection of the composition comprises guidance from an ultrasonographic examination while observing a state of permeation of the composition into the tumor.

30. The method according to claim 22, wherein the composition consists of: (a) 0.1 to 2 weight percent of hydrogen peroxide in a final formulation; (b) the gelatin; and optionally (c) at least one component selected from the group consisting of water, L-methionine, sodium chloride, sodium hydrogenphosphate, crystalline sodium dihydrogen phosphate, glycerin, glucose, polyethylene glycol, propylene_glycol, D-mannitol, fructose, xylitol, sodium dihydrogen phosphate, sodium phosphate, hydrochloric acid, sodium hydroxide, a phosphoric acid buffer solution, a tris buffer solution, and an acetic acid buffer solution.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0111] FIG. 1 shows the effect of the radiosensitization method of a malignant melanoma conducted in Reference Example 1. FIG. 1 at the upper left is an image showing the malignant melanoma area prior to radiotherapy, FIG. 1 at the upper right is an image showing the malignant melanoma area at the end of sensitized irradiation (48 Gy), FIG. 1 at the lower left is an image showing the malignant melanoma area two weeks after the end of the radiosensitization therapy, and FIG. 1 at the lower right is an image showing the malignant melanoma area three months after the end of the radiosensitization therapy.

[0112] FIG. 2 shows the effect of the radiosensitization method of a malignant fibrous histiocytoma conducted in Example 2. FIG. 2 on the upper-left is an image showing the blood-flow signals in the tumor after irradiation (total dose of 24 Gy) of the malignant fibrous histiocytoma without injection of a radiosensitizer, FIG. 2 on the upper right and 2 on the lower left are images showing blood-flow signals in the tumor after the histiocytoma is injected with a radiosensitizer and irradiated (upper-right FIG. 2: total dose of 36 Gy, lower-left Figure: total dose of 48 Gy), and FIG. 2 on the lower right is an image showing the blood-flow signals in the tumor one week after the end of the radiotherapy.

[0113] FIG. 3 shows an example of the use of the radiosensitizer of Example 3. FIG. 3 on the left is an image showing the right side of the patient's chest, from the thorax to the neck region, FIG. 3 on the upper right is a coronal image of the part obtained by computerized tomography (CT), and FIG. 3 on the lower right is a PET-CT frontal image of the patient.

[0114] FIG. 4 shows the effect of the radiosensitization method conducted in Example 3. FIG. 4 on the upper left is a CT image of the neck area prior to radiotherapy, and FIG. 4 on the lower left is a CT image of the right axilla prior to radiotherapy. FIG. 4 on the upper right is a CT image taken after the neck has been irradiated seven times (total dose of 19.25 Gy) without injecting a radiosensitizer, and FIG. 4 on the lower right is a CT image taken after the right axilla has been injected with a radiosensitizer and irradiated seven times (total dose of 19.25 Gy).

[0115] FIG. 5 shows the effect of the anti-cancer chemotherapy sensitization conducted in Example 4. The left side shows a CT image taken prior to anti-cancer chemotherapy sensitization, and the right side shows a CT image taken after anti-cancer chemotherapy sensitization.

[0116] FIG. 6 shows the effect of the anti-cancer chemotherapy sensitization conducted in Example 4. The left side shows a CT image taken prior to anti-cancer chemotherapy sensitization, and the right side shows a CT image taken after anti-cancer chemotherapy sensitization.