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

NCT00156299 | Terminated Phase 1

• 3 other identifiers: CDR0000540303P30CA072720020201
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myelomonocytic leukemia (M4); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); untreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Temporal changes in leukemic cell NF-kB activity

  5 years

Secondary Outcomes (2)

• Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate

  5 years

• Apoptosis related to NF-kB modulation

  5 years

Study Arms (2)

Dexamethasone plus Choline Magnesium Trisalicylate

EXPERIMENTAL

Dexamethasone plus Choline Magnesium Trisalicylate

Drug: choline magnesium trisalicylate; Drug: Dexamethasone

Choline Magnesium Trisalicylate

EXPERIMENTAL

Choline Magnesium Trisalicylate

Drug: choline magnesium trisalicylate

Interventions

choline magnesium trisalicylate DRUG

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

Choline Magnesium Trisalicylate; Dexamethasone plus Choline Magnesium Trisalicylate

Dexamethasone DRUG

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

Dexamethasone plus Choline Magnesium Trisalicylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Related Publications (1)

• Strair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8. doi: 10.1158/1078-0432.CCR-08-1390.

  PMID: 19010875 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute

Interventions

choline magnesium trisalicylate; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Roger Strair, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (1)