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

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 1

Conditions: Leukemia

Treatments: Drug: Dexamethasone; Drug: choline magnesium trisalicylate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00156299

P30CA072720 (U.S. NIH Grant/Contract)

020201

CDR0000540303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed acute myeloid leukemia

  • Newly diagnosed disease

• Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies

• Leukemic blast count > 5,000/mm³ of peripheral blood

• No acute promyelocytic leukemia (M3)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-3

• Bilirubin < 2.0 times upper limit of normal (ULN)

• AST < 3.0 times ULN

• Creatinine < 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance

• No other concurrent medical condition that would preclude study compliance

• No allergies to any investigational drugs and/or chemotherapeutic agents

• No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy

  • No clinical diagnosis of GI bleeding requiring blood transfusions

PRIOR CONCURRENT THERAPY:

• No prior induction therapy
• No prior chemotherapy for acute leukemia
• No concurrent medications that would preclude study compliance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Dexamethasone plus Choline Magnesium Trisalicylate

Experimental group

Description:

Dexamethasone plus Choline Magnesium Trisalicylate

Treatment:

Drug: choline magnesium trisalicylate

Drug: Dexamethasone

Choline Magnesium Trisalicylate

Experimental group

Description:

Choline Magnesium Trisalicylate

Treatment:

Drug: choline magnesium trisalicylate