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

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Choline; Choline magnesium trisalicylate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Salicylates

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