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A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Grade II Graft vs. Host Disease With Gastrointestinal Symptoms


Phase 3
N/A
N/A
Not Enrolling
Both
Graft Versus Host Disease

Thank you

Trial Information

A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Grade II Graft vs. Host Disease With Gastrointestinal Symptoms


OBJECTIVES:

- Compare the efficacy of beclomethasone dipropionate and prednisone vs placebo and
prednisone, in terms of time to treatment failure, in patients with grade II
graft-vs-host disease with gastrointestinal symptoms.

- Compare the proportion of treatment failures on study days 10, 30, 50, 60, and 80 in
patients treated with these regimens.

- Compare the cumulative systemic corticosteroid exposure in patients treated with these
regimens.

- Compare the incidence and degree of hypothalamic-pituitary-adrenal axis suppression in
patients treated with these regimens who have not experienced treatment failure by
study day 50.

- Compare the safety of these regimens in these patients.

- Compare the total deaths and causes of death through 200 days post-transplantation of
patients treated with these regimens.

- Assess the pharmacokinetic profile of beclomethasone dipropionate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter
study. Patients are stratified according to graft tissue source (2 HLA haplotype-identical
sibling vs all others) and topical steroid use at baseline (yes vs no). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral beclomethasone dipropionate 4 times daily on days 1-50.
Patients also receive oral prednisone (or methylprednisolone IV) twice daily on days
1-10 with a rapid taper on days 11-17 followed by low-dose prednisone on days 18-80.

- Arm II: Patients receive oral placebo 4 times daily on days 1-50. Patients also receive
prednisone (or methylprednisolone) as in arm I.

In both arms, treatment continues in the absence of poorly controlled GVHD at day 10 or
unacceptable toxicity.

Patients are followed at days 51, 60, and 80 and then at 200 days post-transplantation.

PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed graft-vs-host disease (GVHD) with gastrointestinal symptoms

- Endoscopic evidence of grade II intestinal GVHD without another plausible
etiology

- Confirmed by biopsy of colon, stomach, small intestine, esophagus, or skin
within 72 hours prior to study entry

- At least 10 days post allogeneic hematopoietic stem cell transplantation

- Received prior anti-candidal prophylaxis of the oropharynx with an effective drug

- Confirmed absence of intestinal infection within the past 7 days

- No liver GVHD with bilirubin greater than 3 mg/dL

- No skin GVHD other than a slowly evolving rash that involves no more than 50% of the
body surface

- No more than 1,000 mL/day of diarrhea on any 1 day within the past 3 days

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Not specified

Life expectancy

- At least 3 months

Hematopoietic

- Not specified

Hepatic

- See Disease Characteristics

Renal

- Not specified

Other

- HIV negative

- Able to swallow tablets

- No multi-organ failure

- No sepsis syndrome

- No other condition with high mortality

- No infection of the mouth or esophagus with a fungal organism

- No persistent vomiting of oral intake

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- At least 30 days since prior biologic agents

Chemotherapy

- Not specified

Endocrine therapy

- At least 30 days since prior systemic (oral or parenteral) prescription
corticosteroids administered for prophylaxis or treatment of GVHD or another
inflammatory disease process

- Concurrent dexamethasone as an antiemetic or to lessen side effects during medication
or blood product administration allowed

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- No prior beclomethasone dipropionate

- At least 30 days since prior investigational drugs or devices

- Concurrent immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus,
methotrexate, or mycophenolate mofetil) allowed for GVHD prophylaxis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Miguel-Angel Perales, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

ENTERON-00-02

NCT ID:

NCT00043147

Start Date:

April 2002

Completion Date:

January 2005

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • Graft vs Host Disease

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021