Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156299
Status:
TERMINATED
Last Update Posted:
2013-11-19
First Post:
2005-09-08
Brief Title:
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Pilot Study of Nuclear Factor-kappa B NFkB Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia AML
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Replaced by another study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate
PURPOSE This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia
PURPOSE This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia
Determine toxicities of this regimen in these patients
Secondary
Determine patterns of leukemic cell gene expression in patients treated with this regimen
Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen
OUTLINE This is an open-label pilot study
Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician
Blood is collected at baseline 24 hours and 48 hours to assess for changes in NF-kB expression apoptosis and gene expression in leukemic cells
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Primary
Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia
Determine toxicities of this regimen in these patients
Secondary
Determine patterns of leukemic cell gene expression in patients treated with this regimen
Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen
OUTLINE This is an open-label pilot study
Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician
Blood is collected at baseline 24 hours and 48 hours to assess for changes in NF-kB expression apoptosis and gene expression in leukemic cells
PROJECTED ACCRUAL A total of 24 patients 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 |
|---|---|---|---|
| 020201 | OTHER | CINJ | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |