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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00043147

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 III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Cancer

Drug Information available for: Prednisone Methylprednisolone Beclomethasone Beclomethasone dipropionate

U.S. FDA Resources

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

Study Start Date:

April 2002

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

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

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Miguel-Angel Perales, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000256305, MSKCC-01149, ENTERON-00-02, NCI-G02-2098, RPCI-DS-01-09
Study First Received:	August 5, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00043147 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

graft versus host disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Respiratory System Agents
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Beclomethasone
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Therapeutic Uses
Methylprednisolone Hemisuccinate

Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Anti-Asthmatic Agents
Glucocorticoids
Protective Agents
Pharmacologic Actions
Autonomic Agents
Prednisolone
Graft vs Host Disease
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010