Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268385
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2005-12-20
Brief Title:
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Vorinostat Suberoylanilide Hydroxamic Acid SAHA in Combination With Temozolomide in Patients With Malignant Gliomas
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 is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas Drugs used in chemotherapy such as vorinostat and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug Giving vorinostat together with temozolomide may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of vorinostat suberoylanilide hydroxamic acid SAHA in combination with temozolomide in patients with malignant gliomas
II To characterize the safety profile of vorinostat SAHA in combination with temozolomide
SECONDARY OBJECTIVES
I To characterize the pharmacokinetics of vorinostat SAHA in combination with temozolomide
II To determine efficacy of vorinostat SAHA in combination with temozolomide as measured by objective response
TERTIARY OBJECTIVES
I To explore the association of response to treatment to the molecular phenotype of the tumor
II To assess the effects of vorinostat SAHA on histone acetylation status in peripheral mononuclear cells
OUTLINE This is a 2-part dose-escalation study of vorinostat
PART I Patients receive vorinostat orally PO once QD or twice daily BID on days 1-7 and 15-21 OR QD or BID on days 1-7 Patients also receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity Beginning in course 2 some patients may receive a higher dose of temozolomide Treatment may continue beyond 13 courses at the discretion of the investigator
PART II Patients receive vorinostat and temozolomide as in part 1
Note Beginning in course 2 all patients receive a higher dose of temozolomide
After completion of study treatment patients are followed up periodically
I To determine the maximum tolerated dose MTD of vorinostat suberoylanilide hydroxamic acid SAHA in combination with temozolomide in patients with malignant gliomas
II To characterize the safety profile of vorinostat SAHA in combination with temozolomide
SECONDARY OBJECTIVES
I To characterize the pharmacokinetics of vorinostat SAHA in combination with temozolomide
II To determine efficacy of vorinostat SAHA in combination with temozolomide as measured by objective response
TERTIARY OBJECTIVES
I To explore the association of response to treatment to the molecular phenotype of the tumor
II To assess the effects of vorinostat SAHA on histone acetylation status in peripheral mononuclear cells
OUTLINE This is a 2-part dose-escalation study of vorinostat
PART I Patients receive vorinostat orally PO once QD or twice daily BID on days 1-7 and 15-21 OR QD or BID on days 1-7 Patients also receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity Beginning in course 2 some patients may receive a higher dose of temozolomide Treatment may continue beyond 13 courses at the discretion of the investigator
PART II Patients receive vorinostat and temozolomide as in part 1
Note Beginning in course 2 all patients receive a higher dose of temozolomide
After completion of study treatment patients are followed up periodically
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-2009-00675 | REGISTRY | None | None |
| NABTC 04-03 | None | None | None |
| CDR0000450762 | None | None | None |
| NABTC04-03 | OTHER | None | None |
| NABTC-04-03 | OTHER | None | None |
| U01CA137443 | NIH | None | None |
| U01CA062399 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062399 |