Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392353
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2006-10-25
Brief Title:
Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 12 Study of Vorinostat Suberoylanilide Hydroxamic Acid SAHA in Combination With Azacitidine in Patients With the Myelodysplastic Syndrome MDS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This phase III trial studies the side effects and best dose of vorinostat and azacitidine and to see how well they work in treating patients with myelodysplastic syndromes or acute myeloid leukemia Vorinostat may stop the growth of cancer or abnormal cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as azacitidine work in different ways to stop the growth of cancer or abnormal cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving vorinostat together with azacitidine may kill more cancer or abnormal cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and toxicity of vorinostat in combination with azacitidine in patients with myelodysplastic syndromes MDS and some select patients with acute myeloid leukemia AML step 1
II To identify doses of both vorinostat and azacitidine for safe combination of the 2 agents that can be administered in repetitive cycles over time for use in phase II studies
III To determine the response rate of patients treated with the combination of suberoylanilide hydroxamic acid SAHA vorinostat and azacitidine at the doses established as safe and effective in Step 1 in an expanded cohort of patients with MDS
IV To obtain preliminary data on the effects of treatment with the combination of vorinostat and Aza C azacitidine in patients with MDS on a series of biologic surrogate markers including deoxyribonucleic acid DNA methylation of specific genes eg p15 histone acetylation hematopoietic progenitor growth and differentiation the fate of the MDS clone and changes in gene expression by array profiling
SECONDARY OBJECTIVES
I Determine effect of treatment with the combination on time to response time to leukemic transformation and frequency of transformation to leukemia in patients with MDS during the phase II segment of the study
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Patients receive azacitidine subcutaneously SC once daily QD on days 1-7 and vorinostat orally PO 2-3 times daily on days 3-5 3-9 or 3-16 Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 6 months and then every 2 months thereafter
I To evaluate the safety and toxicity of vorinostat in combination with azacitidine in patients with myelodysplastic syndromes MDS and some select patients with acute myeloid leukemia AML step 1
II To identify doses of both vorinostat and azacitidine for safe combination of the 2 agents that can be administered in repetitive cycles over time for use in phase II studies
III To determine the response rate of patients treated with the combination of suberoylanilide hydroxamic acid SAHA vorinostat and azacitidine at the doses established as safe and effective in Step 1 in an expanded cohort of patients with MDS
IV To obtain preliminary data on the effects of treatment with the combination of vorinostat and Aza C azacitidine in patients with MDS on a series of biologic surrogate markers including deoxyribonucleic acid DNA methylation of specific genes eg p15 histone acetylation hematopoietic progenitor growth and differentiation the fate of the MDS clone and changes in gene expression by array profiling
SECONDARY OBJECTIVES
I Determine effect of treatment with the combination on time to response time to leukemic transformation and frequency of transformation to leukemia in patients with MDS during the phase II segment of the study
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Patients receive azacitidine subcutaneously SC once daily QD on days 1-7 and vorinostat orally PO 2-3 times daily on days 3-5 3-9 or 3-16 Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 6 months and then every 2 months thereafter
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 |
|---|---|---|---|
| NYCC-6898 | None | None | None |
| NCI-2009-01050 | REGISTRY | None | None |
| 11-1773 | None | None | None |
| NCI-6898 | None | None | None |
| CDR0000511887 | None | None | None |
| 6898 | OTHER | None | None |
| N01CM17103 | NIH | None | None |
| 6898 | OTHER | None | None |
| N01CM62204 | NIH | None | None |
| P30CA013330 | NIH | CTEP | httpsreporternihgovquickSearchP30CA013330 |