Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate

Phase 1

Terminated

• Conditions: Leukemia
• Interventions: Drug: choline magnesium trisalicylate; Drug: Dexamethasone

• Registration Number: NCT00156299
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone plus Choline Magnesium Trisalicylate	choline magnesium trisalicylate	Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate	Dexamethasone	Dexamethasone plus Choline Magnesium Trisalicylate
Choline Magnesium Trisalicylate	choline magnesium trisalicylate	Choline Magnesium Trisalicylate

Primary Outcome Measures

Name	Time	Method
Temporal changes in leukemic cell NF-kB activity	5 years

Secondary Outcome Measures

Name	Time	Method
Apoptosis related to NF-kB modulation	5 years
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate	5 years

Trial Locations

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States