Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005634
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Clinical and Pharmacological Study of Suberoylanilide Hydroxamic Acid- SAHA MSK390 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of suberoylanilide hydroxamic acid SAHA in patients with refractory malignancies II Assess the pharmacokinetic profile of SAHA in these patients III Assess the biologic effects of SAHA on normal tissues and on tumor cells in these patients
OUTLINE This is a dose-escalation study Patients receive suberoylanilide hydroxamic acid SAHA IV over 2 hours on days 1-3 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Accelerated Phase One patient per dose level receives escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which a patient experiences grade 2 or greater toxicity other than hemoglobin anemia with the first course or when 2 different patients experience a grade 2 toxicity other than hemoglobin anemia during any course of treatment Standard Phase Cohorts of 3-6 patients receive escalating doses of SAHA until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 45 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive suberoylanilide hydroxamic acid SAHA IV over 2 hours on days 1-3 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Accelerated Phase One patient per dose level receives escalating doses of SAHA until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which a patient experiences grade 2 or greater toxicity other than hemoglobin anemia with the first course or when 2 different patients experience a grade 2 toxicity other than hemoglobin anemia during any course of treatment Standard Phase Cohorts of 3-6 patients receive escalating doses of SAHA until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 45 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-H00-0051 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067789 | REGISTRY | None | None |