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Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.

Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.

choline magnesium trisalicylate

idarubicin

cytarabine

laboratory biomarker analysis

Roger Strair

This randomized phase II trial studies how well choline magnesium trisalicylate with idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet know whether choline magnesium trisalicylate and combination chemotherapy is more effective than combination chemotherapy alone in treating patients with acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. To determine temporal changes in leukemic cell nuclear factor of kappa light chain enhancer of B-cells 1 (NF-kB) activity when salicylate (choline magnesium trisalicylate) is administered to patients with acute myeloid leukemia (AML) during induction chemotherapy.

II. To determine toxicities associated with administration of salicylate in the setting of induction chemotherapy.

III. To determine if salicylate alters the expression of NF-kB-regulated genes in AML cells.

IV. To determine if NF-kB modulation by salicylate alters AML chemotherapy drug efflux.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive choline magnesium trisalicylate orally (PO) every 8 hours on days 0-7, idarubicin intravenously (IV) on days 1-3, and cytarabine IV continuously on days 1-7.

ARM II: Patients receive idarubicin IV on days 1-3 and cytarabine IV continuously on days 1-7.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

A Randomized Phase II Study of Nuclear Factor-kappa B (NF-κB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia

The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients.

Rutgers Cancer Institute of New Jersey

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Professor of Medicine, RWJMS

Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.

choline magnesium trisalicylate: Given PO

idarubicin: Given IV

cytarabine: Given IV

laboratory biomarker analysis: Correlative studies

Arm I (Choline Magnesium Trisalicylate and Chemotherapy)

Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.

idarubicin: Given IV

cytarabine: Given IV

laboratory biomarker analysis: Correlative studies

Arm II (Chemotherapy)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Roger Strair, MD, PhD

Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients

Overall Study

Hematologic Neoplasms

Antiemetics

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12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)

The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15). Up to 6 cycles.

12-O-tetradecanoylphorbol-13-acetate

Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.

Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.

Up to 6 cycles.

This phase II trial is studying the side effects and how well giving tetradecanoylphorbol acetate together with dexamethasone and choline magnesium trisalicylate works in treating patients with relapsed or refractory acute myeloid leukemia.

Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies

A Phase II Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) Plus Dexamethasone & Choline Magnesium Trisalicylate in the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia

Biosuccess Biotech Co., Ltd.

12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone \& Choline magnesium trisalicylate (Trilisate)

12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).

Up to 6 cycles.

Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.

Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.

Up to 6 cycles.

TPA + Dexamethasone and CMT

Tatiana Zelinskaya

The study participant died before the study data collection completed.

Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)

Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%

Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression

Dexamethasone plus Choline Magnesium Trisalicylate

1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.

10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.

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.

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.

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

A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia	NCT02144675	Adult Acute Meg... Adult Acute Min... Adult Acute Mon... Adult Acute Mon... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Erythrole... Adult Pure Eryt... Recurrent Adult... Untreated Adult...	choline magnesi... idarubicin cytarabine laboratory biom...	18 Years -	Rutgers, The State University of New Jersey
Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia	NCT02144675	Adult Acute Meg... Adult Acute Min... Adult Acute Mon... Adult Acute Mon... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Acute Mye... Adult Erythrole... Adult Pure Eryt... Recurrent Adult... Untreated Adult...	choline magnesi... idarubicin cytarabine laboratory biom...	18 Years -	Rutgers, The State University of New Jersey
Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies	NCT01009931	Leukemia	12-O-tetradecan... Dexamethasone Choline magnesi...	18 Years -	Rutgers, The State University of New Jersey
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate	NCT00156299	Leukemia	choline magnesi... Dexamethasone	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for choline magnesium trisalicylate