Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492921
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2007-06-25
Brief Title:
High-Dose Cyclophosphamide for Steroid Refractory GVHD
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy
Status:
COMPLETED
Status Verified Date:
2018-09
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 High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy
PURPOSE This phase II trial is studying the side effects best dose and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy
PURPOSE This phase II trial is studying the side effects best dose and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease GVHD
Determine the efficacy of this regimen at 28 days post-treatment in these patients
OUTLINE This is a dose-escalation study
Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim G-CSF subcutaneously once daily beginning on day 10 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed weekly for 4 weeks
Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease GVHD
Determine the efficacy of this regimen at 28 days post-treatment in these patients
OUTLINE This is a dose-escalation study
Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim G-CSF subcutaneously once daily beginning on day 10 and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed weekly for 4 weeks
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 |
|---|---|---|---|
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| NA_00003256 | OTHER | JHMIRB | httpsreporternihgovquickSearchP30CA006973 |