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Clinical Trial VICCBMT1381

Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Orbec? (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by Graft vs Host Disease (GVHD) in Patients with Chronic GI GVHD

Principal Investigator(s)

Bipin Savani

Details

  • Protocol No. VICCBMT1381
  • Open Date: 01/23/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: The primary efficacy objective of this study is to estimate the proportion of subjects who achieve a complete response (CR), partial response (PR) and overall response (OR) of gastrointestinal graft versus host disease (GI GVHD) signs and symptoms when treated with oral BDP, 2 mg q.i.d. (8 mg/day) versus placebo, for up to 16 weeks, in patients with chronic GVHD (cGVHD).
  • Disease Sites: Gastrointestinal; Pancreatic; Esophageal; Colon
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: orBec
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01925950
  • Secondary Protocol No: BDP-GVHD-08

Description

Patients are being asked to take part in this research study because they have chronic graft-versus-host disease (cGVHD) with gastrointestinal symptoms (GI GVHD). In this study we want to know if a drug called beclomethasone dipropionate (BDP, also called orBec) is safe and effective to treat chronic GI GVHD (GI cGVHD). The use of BDP is investigational or experimental. The U.S. Food and Drug Administration (FDA) has approved other forms of BDP for other uses, but the FDA has not approved BDP for treating or preventing chronic GI GVHD. We want to find out if taking BDP pills is safe and effective in patients with chronic graft-versus-host disease (cGVHD) with gastrointestinal symptoms (GI GVHD). The only way to find out if BDP can help treat GI cGVHD is to test BDP in patients. Sometimes after a bone marrow or stem cell transplant, the cells from your donor see your body as foreign and attack it. This condition is called chronic graft-versus-host disease (cGVHD). Chronic GI GVHD can cause decreased appetite, nausea, vomiting and diarrhea. When cGVHD occurs, the usual treatment is long term use of drugs given to weaken the immune system. Drugs used for this purpose include prednisone. These drugs are usually effective for helping GVHD at first but then can cause side effects. BDP is a strong form of steroid drug (like prednisone). BDP can be taken by mouth in pill form. BDP is able to reduce inflammation (swelling) in the stomach, intestines and liver. BDP is poorly absorbed by the body when taken by mouth and seems to work directly on the surface of the gut. Recent studies show that BDP may be better than prednisone in treating GI cGVHD.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
• Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
• Endoscopic findings consistent with GI GVHD
• Must be able to swallow tablets
• Must be able to read and understand informed consent
• Adequate birth control methods for the duration of the study
Exclusion Criteria:
• >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
• GI infection
• Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• HIV seropositivity
• Pregnant or nursing female
• Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
• Evidence of recurrent or progressing malignant disorder that was the indication for HCT