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Beclomethasone Plus Prednisone in Treating Patients With Graft-Versus-Host Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00043147
First received: August 5, 2002
Last updated: May 29, 2013
Last verified: December 2004
  Purpose

RATIONALE: Beclomethasone combined with prednisone may be an effective treatment for graft-versus-host disease caused by stem cell transplantation. It is not yet known if prednisone is more effective with or without beclomethasone in treating gastrointestinal graft-versus-host disease.

PURPOSE: Randomized phase III trial to determine the effectiveness of prednisone with or without beclomethasone in treating patients who have graft-versus-host disease afftecting the gastrointestinal system.


Condition Intervention Phase
Graft Versus Host Disease
Drug: beclomethasone dipropionate
Drug: methylprednisolone
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Study Completion Date: January 2005
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043147

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Miguel-Angel Perales, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00043147     History of Changes
Other Study ID Numbers: ENTERON-00-02, MSKCC-01149, CDR0000256305, NCI-G02-2098, RPCI-DS-01-09
Study First Received: August 5, 2002
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Beclomethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014