Low Dose IL-2 for Ulcerative Colitis
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.
Study Start Date
Estimated Completion Date
- Drug: Interleukin-2 (aldesleukin).
- Gastroenterology: Inflammatory Bowel Dz
- Pharmacy: Stomach/GI
- Physician Assistant: Gastroenterology
- Ulcerative Colitis
Children's Hospital Boston -- IRB-P00009599
Children's Hospital Boston
- Age 18-30 years.
- A diagnosis of UC made by standard clinical, radiological, endoscopic and histological criteria.
- Moderate to severe UC with a Mayo score of 6-12.
- Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (examples include oral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine, or a tumor necrosis factor (TNF) antagonist). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.
- Stable doses of concomitant medications.
- A negative pregnancy test in the 2 weeks prior to anticipated commencement of the study drug, in female subjects of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- Ability to provide informed consent.
- A diagnosis of Crohn's disease or Inflammatory Bowel Disease
- Unspecified (IBD-U, a diagnostic classification formerly termed "indeterminate colitis").
- Requirement for immediate surgical, endoscopic or radiological intervention for toxic megacolon, massive hemorrhage, perforation, sepsis, or intra-abdominal or perianal abscess.
- Ileostomy, proctocolectomy or subtotal colectomy with ileorectal anastomosis.
- History of colorectal cancer or dysplasia.
- Positive stool test for Clostridium difficile.
- Current medically significant infection.
- Significant laboratory abnormalities, including 1. Hb < 8.0 g/dL, WBC < 2.5 x 103/mm3, Plt < 100 x 103/mm3. 2. Creatinine ? 1.5x institutional upper limit of normal (ULN). 3. Total bilirubin > 2.0 mg/dL, ALT > 2x institutional ULN, GGT > 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed. 4. Abnormal thyroid function tests.
- Positive serology for HIV, hepatitis B virus (HBV) or HCV.
- Positive screening test for tuberculosis (TB).
- First dose of an anti-TNF medication within 4 weeks of anticipated study commencement, or a subsequent dose within 2 weeks of commencement or ciclosporin or tacrolimus within 2 weeks of anticipated study commencement.
- Received another investigational new drug (IND) within 5 half-lives of that agent before the planned commencement of SC IL-2.
- Malignancy within the last 5 years.
- Allergy to any component of the study drug.
- Pregnant or lactating women.
- Inability to comply with the study protocol or inability to give informed consent.
- Prior exposure to IL-2.
- Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).
18 Years to 30 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (2)
|Brigham Womens Hospital - Boston, Massachusetts||2.6 miles||Madeline Carrellas BS||Noneemail@example.com|
|Boston Childrens Hospital - Boston, Massachusetts||2.6 miles||Alexandra Griffith BSfirstname.lastname@example.org|