PREVENTION, TREATMENT, AND AMELIORATION OF RADIATION INDUCED ENTERITIS
The present invention provides a new method of ameliorating and/or treating enteritis induced by radiation therapy, alone or in combination with other therapies, for the treatment oil for example, gastrointestinal malignancies, including colorectal, appendiceal, anal, or small bowel cancers; urogenital malignancies, including prostate, bladder, testicular, or penile cancers; gynecologic malignancies, including cervical, endometrial, ovarian, vaginal, or vulvar cancers; or osteogenic and other sarcomatous malignancies in which pelvic structures are involved, comprising the administration of a therapeutically effective amount of balsalazide to a patient in need thereof
1 - 26 . (canceled)
27 . A method of treating radiation induced enteritis comprising administering to a subject in need thereof a therapeutically effective amount of balsalazide.
28 . The method of claim 27 , wherein the balsalazide is administered during radiation therapy.
29 . The method of claim 27 , wherein the balsalazide is administered for at least one day after the cessation of radiation therapy.
30 . The method of claim 27 , wherein the balsalazide is administered for fourteen days after the cessation of radiation therapy.
31 . The method of claim 27 , wherein the subject received radiotherapy as a result of treatment for gastrointestinal malignancies selected from colorectal, appendiceal, anal, or small bowel cancers; urogenital malignancies selected from prostate, bladder, testicular, or penile cancers; gynecologic malignancies selected from cervical, endometrial, ovarian, vaginal, or vulvar cancers; or osteogenic and other sarcomatous malignancies in which pelvic structures are involved.
32 . The method of claim 27 , wherein the balsalazide is administered twice daily to the subject.
33 . The method of claim 27 , wherein from between about 3,000 mg to about 5000 mg of balsalazide is administered to the subject daily.
34 . The method of claim 27 , wherein the balsalazide is administered to the subject from between about 8 weeks to about 12 weeks.
35 . The method of claim 27 , wherein the subject has acute radiation enteritis.
36 . The method of claim 27 , wherein the radiation induced enteritis is caused by radiation therapy in combination with chemotherapy or a surgical procedure.
37 . The method of claim 36 , wherein the balsalazide is administered during radiation therapy, chemotherapy, or the surgical procedure.
38 . The method of claim 36 , wherein the balsalazide is administered for at least one day after the cessation of radiation therapy, chemotherapy, or after the surgical procedure.
39 . The method of claim 36 , wherein the balsalazide is administered for fourteen days after the cessation of radiation therapy, chemotherapy, or after the surgical procedure.
40 . The method of claim 36 , wherein the subject received radiotherapy, chemotherapy, or surgical procedure as a result of treatment for gastrointestinal malignancies selected from colorectal, appendiceal, anal, or small bowel cancers; urogenital malignancies selected from prostate, bladder, testicular, or penile cancers; gynecologic malignancies selected from cervical, endometrial, ovarian, vaginal, or vulvar cancers; or osteogenic and other sarcomatous malignancies in which pelvic structures are involved.
41 . The method of claim 36 , wherein the balsalazide is administered twice daily to the subject.
42 . The method of claim 36 , wherein from between about 3,000 mg to about 5000 mg of balsalazide is administered to the subject daily.
43 . The method of claim 36 , wherein the balsalazide is administered to the subject from between about 8 weeks to about 12 weeks.