Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045006
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-09-06
Brief Title:
Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid - SAHA MSK390 in Patients With Advanced Solid Tumors and Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2003-10
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 Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of suberoylanilide hydroxamic acid in patients with advanced solid tumors or hematologic malignancies
Evaluate the pharmacokinetic profile of this drug in these patients
Determine the effects of this drug on absorption in the fasting and non-fasting states in these patients
Determine any anti-tumor effects of this drug in these patients
Correlate clinical outcomes with histone acetylation in circulating mononuclear cells and tumor biopsy samples in patients treated with this drug
OUTLINE This is a dose-escalation study Patients are stratified according to disease solid tumor vs multiple myeloma or lymphoma vs leukemia or myelodysplastic syndromes
The initial 15-20 patients in the solid tumor or multiple myeloma or lymphoma stratum receive suberoylanilide hydroxamic acid SAHA IV over 2 hours on day 1 of week 0 and then orally once or twice daily beginning on day 1 of week 1 All remaining patients receive oral SAHA once or twice daily beginning on day 1 of week 1 Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
In each stratum cohorts of 3-6 patients receive escalating doses of SAHA 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
Patients are followed monthly for resolution of adverse events
PROJECTED ACCRUAL A maximum of 114 patients 42 with solid tumors 36 with lymphoma or multiple myeloma and 36 with leukemia or myelodysplastic syndromes will be accrued for this study within 1 year
Determine the maximum tolerated dose of suberoylanilide hydroxamic acid in patients with advanced solid tumors or hematologic malignancies
Evaluate the pharmacokinetic profile of this drug in these patients
Determine the effects of this drug on absorption in the fasting and non-fasting states in these patients
Determine any anti-tumor effects of this drug in these patients
Correlate clinical outcomes with histone acetylation in circulating mononuclear cells and tumor biopsy samples in patients treated with this drug
OUTLINE This is a dose-escalation study Patients are stratified according to disease solid tumor vs multiple myeloma or lymphoma vs leukemia or myelodysplastic syndromes
The initial 15-20 patients in the solid tumor or multiple myeloma or lymphoma stratum receive suberoylanilide hydroxamic acid SAHA IV over 2 hours on day 1 of week 0 and then orally once or twice daily beginning on day 1 of week 1 All remaining patients receive oral SAHA once or twice daily beginning on day 1 of week 1 Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
In each stratum cohorts of 3-6 patients receive escalating doses of SAHA 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
Patients are followed monthly for resolution of adverse events
PROJECTED ACCRUAL A maximum of 114 patients 42 with solid tumors 36 with lymphoma or multiple myeloma and 36 with leukemia or myelodysplastic syndromes will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2099 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256306 | REGISTRY | None | None |
| ATON-0101 | None | None | None |