Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015925
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2001-05-06
Brief Title:
MS-275 in Treating Patients With Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Clinical-Labratory Study of the Histone Deacetylase HDA Inhibitor MS-275 in Adults With Refractory and Relapsed Hematologic Malignancies
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of MS-275 in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of MS-275 in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk hematologic malignancy
Determine whether this drug induces changes in hematologic differentiation in terms of changes in morphology cell surface marker expression and acetylation status in these patients
Determine whether this drug induces clinical response in these patients
OUTLINE This is a dose-escalation study
Patients receive oral MS-275 on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk hematologic malignancy
Determine whether this drug induces changes in hematologic differentiation in terms of changes in morphology cell surface marker expression and acetylation status in these patients
Determine whether this drug induces clinical response in these patients
OUTLINE This is a dose-escalation study
Patients receive oral MS-275 on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-2791 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| U01CA069854 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0253 | None | None | None |
| MSGCC-0050 | None | None | None |