Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109824
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2005-05-03
Brief Title:
Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With RelapsedRefractory Non-Hodgkins Lymphoma
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:
Drugs used in chemotherapy such as decitabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving decitabine together with valproic acid may be an effective treatment for non-Hodgkins lymphoma This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the minimally effective pharmacological dose MEPD of single-agent decitabine in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma
II Determine the maximum tolerated dose of valproic acid when administered with the MEPD of decitabine in these patients
III Determine the MEPD of valproic acid when administered with decitabine in these patients
IV Determine the toxic effects of decitabine alone and in combination with valproic acid in these patients
SECONDARY OBJECTIVES
I Determine the response rate in patients treated with these drugs II Determine the pharmacokinetics of these drugs in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 treatment stages
STAGE 1 Patients receive decitabine IV over 1 hour on days 1-5 or 1-10 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
STAGE 2 Patients receive decitabine as in stage 1 and valproic acid orally PO thrice daily TID on days 5-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
For both stages patients who achieve an objective response complete response CR unconfirmed CR or partial response may discontinue study treatment and undergo stem cell transplantation if eligible
PROJECTED ACCRUAL Approximately 18-42 patients 18 for stage 1 and 24 for stage 2 will be accrued for this study
I Determine the minimally effective pharmacological dose MEPD of single-agent decitabine in patients with relapsed or refractory aggressive B-cell non-Hodgkins lymphoma
II Determine the maximum tolerated dose of valproic acid when administered with the MEPD of decitabine in these patients
III Determine the MEPD of valproic acid when administered with decitabine in these patients
IV Determine the toxic effects of decitabine alone and in combination with valproic acid in these patients
SECONDARY OBJECTIVES
I Determine the response rate in patients treated with these drugs II Determine the pharmacokinetics of these drugs in these patients
OUTLINE This is a dose-escalation study Patients are assigned to 1 of 2 treatment stages
STAGE 1 Patients receive decitabine IV over 1 hour on days 1-5 or 1-10 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
STAGE 2 Patients receive decitabine as in stage 1 and valproic acid orally PO thrice daily TID on days 5-21 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
For both stages patients who achieve an objective response complete response CR unconfirmed CR or partial response may discontinue study treatment and undergo stem cell transplantation if eligible
PROJECTED ACCRUAL Approximately 18-42 patients 18 for stage 1 and 24 for stage 2 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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 0475 | None | None | None |
| CDR0000426523 | None | None | None |
| OSU-0475 | None | None | None |
| NCI-6997 | None | None | None |
| OSU-2004C0119 | None | None | None |