Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336063
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2006-06-08
Brief Title:
Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of 5Azacitidine and Suberoylanilide Hydroxamic Acid in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma and Nasal NK-T Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 I trial studies the side effects and best dose of vorinostat when given together with azacitidine in treating patients with nasopharyngeal cancer or nasal natural killer T-cell lymphoma that has recurred come back at or near the same place as the original primary tumor usually after a period of time during which the cancer could not be detected or has spread to other parts of the body Drugs used in chemotherapy such as vorinostat and azacitidine work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Vorinostat and azacitidine also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving vorinostat together with azacitidine may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Define toxicity profile of escalating doses of suberoylanilide hydroxamic acid SAHA given in conjunction with a fixed dose of 5 Azacytidine 5AC azacitidine in patients with locally recurrent and metastatic nasopharyngeal carcinoma and natural killer NK-T cell nasal lymphoma
II Define the biologically optimal dose of SAHA given in conjunction with a fixed dose of 5AC in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NKT cell nasal lymphoma based on evidence of Epstein-Barr virus EBV lytic induction in tumor biopsies and plasma
III Study the effect of 5AC on the pharmacokinetic of SAHA in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
IV Assess the effect of SAHA on histone acetylation as measured in tumor and peripheral blood mononuclear cells of patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma V Assess the effect of 5AC on EBV promoter demethylation as measured in tumor patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
OUTLINE This is a dose-escalation study of vorinostat SAHA
Patients receive azacitidine subcutaneously SC on days 1-10 and vorinostat orally PO twice daily BID on days 1-14 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with responding disease may continue treatment at the discretion of the principal investigator Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined
I Define toxicity profile of escalating doses of suberoylanilide hydroxamic acid SAHA given in conjunction with a fixed dose of 5 Azacytidine 5AC azacitidine in patients with locally recurrent and metastatic nasopharyngeal carcinoma and natural killer NK-T cell nasal lymphoma
II Define the biologically optimal dose of SAHA given in conjunction with a fixed dose of 5AC in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NKT cell nasal lymphoma based on evidence of Epstein-Barr virus EBV lytic induction in tumor biopsies and plasma
III Study the effect of 5AC on the pharmacokinetic of SAHA in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
IV Assess the effect of SAHA on histone acetylation as measured in tumor and peripheral blood mononuclear cells of patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma V Assess the effect of 5AC on EBV promoter demethylation as measured in tumor patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell nasal lymphoma
OUTLINE This is a dose-escalation study of vorinostat SAHA
Patients receive azacitidine subcutaneously SC on days 1-10 and vorinostat orally PO twice daily BID on days 1-14 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with responding disease may continue treatment at the discretion of the principal investigator Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose MTD is determined
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 |
|---|---|---|---|
| P30CA006973 | NIH | CTEP | httpsreporternihgovquickSearchP30CA006973 |
| NCI-2009-00089 | REGISTRY | None | None |
| NCI-6837 | None | None | None |
| CTRG NP031904 | None | None | None |
| CDR0000472702 | None | None | None |
| CTRG NP031904 | OTHER | None | None |
| 6837 | OTHER | None | None |