Graft Versus Host DiseaseNCT00055666
Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
A study testing beclomethasone dipropionate in people with Graft Versus Host Disease, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract. PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- beclomethasone dipropionate
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinically or pathologically confirmed graft-versus-host disease of the gastrointestinal tract
- Failed standard therapy with or has a contraindication to systemic immunosuppressive agents
- No clinically significant intestinal infection (confirmed by stool culture)
- No persistent vomiting of all oral intake
- Not a candidate for approved beclomethasone dipropionate Enteron Pharmaceuticals protocol
PATIENT CHARACTERISTICS:
Age
- 4 to 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to swallow medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.
PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.
Read the detailed description
OBJECTIVES:
- Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
- Minimize the serious side effects associated with systemic steroid use in these patients.
OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.
PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.
- Conditions
- Graft Versus Host Disease
- Being tested
- beclomethasone dipropionate
- Keywords
- graft versus host disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone dipropionateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startMar 2001
- Primary completionFeb 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Philip L. McCarthy, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055666
- Sponsor's protocol ID
- CDR0000270747
- Other IDs
- RPCI-DS-01-04
- Status last verified
- Mar 2011
- First submitted
- 6 Mar 2003
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT00055666
- Acronym / sponsor ID
- CDR0000270747
- Conditions
- Graft Versus Host Disease
- Keywords
- graft versus host disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Feb 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host disease of the gastrointestinal tract.
PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host disease of the gastrointestinal tract that has not responded to previous therapy.
Detailed description
OBJECTIVES:
- Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host disease refractory to standard therapy or with a contraindication to systemic steroids.
- Minimize the serious side effects associated with systemic steroid use in these patients.
OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then receive a second course for 31 days if symptoms of graft-versus-host disease persist. Patients may receive up to 4 treatments (1 or 2 courses each) per year.
PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone dipropionate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip L. McCarthy, MD study chair
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beclomethasone dipropionate in people with Graft Versus Host Disease, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.