Low Dose IL-2 for Ulcerative Colitis

Description

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

February 2015

Estimated Completion Date

January 2018

Interventions

  • Drug: Interleukin-2 (aldesleukin).

Specialties

  • Gastroenterology: Inflammatory Bowel Dz
  • Pharmacy: Stomach/GI
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Colitis
  • Ulcerative
  • Ulcerative Colitis

Study ID

Children's Hospital Boston -- IRB-P00009599

Status

Unknown

Trial ID

NCT02200445

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

28

Sponsor

Children's Hospital Boston

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Gender

Both

Ages

18 Years to 30 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles Madeline Carrellas BS None mcarrellas@partners.org
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Alexandra Griffith BS 617-919-4592 alexandra.griffith@childrens.harvard.edu

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