Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010283
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2001-02-02
Brief Title:
Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus Stomach Small Intestine or Colon
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease Compassionate Use in Patients With Contraindictions to High-Dose Immunosuppressive Therapy
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Beclomethasone may be an effective treatment for graft-versus-host disease
PURPOSE Phase III trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus stomach small intestine or colon
PURPOSE Phase III trial to study the effectiveness of beclomethasone in treating patients who have graft-versus-host disease of the esophagus stomach small intestine or colon
Detailed Description:
OBJECTIVES I Determine the frequency of treatment success in patients with intestinal graft-versus-host disease with contraindications to high-dose immunosuppressive therapy treated with beclomethasone II Determine the frequency of adverse events related to the use of this drug in these patients III Assess the natural history and outcome of the medical problem for which high-dose immunosuppressive therapy was a contraindication
OUTLINE Patients receive oral beclomethasone 4 times daily for 28 days Treatment may repeat for an additional 28 days as needed Patients are interviewed weekly to assess treatment success and adverse events Patients are followed at 1 and 2 weeks
PROJECTED ACCRUAL A total of 40-100 patients will be accrued for this study within 3 years
OUTLINE Patients receive oral beclomethasone 4 times daily for 28 days Treatment may repeat for an additional 28 days as needed Patients are interviewed weekly to assess treatment success and adverse events Patients are followed at 1 and 2 weeks
PROJECTED ACCRUAL A total of 40-100 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068475 | REGISTRY | PDQ | None |
| FHCRC-150000 | None | None | None |
| RPCI-DS-99-27 | None | None | None |
| NCI-H01-0067 | None | None | None |