Leukemia
Conditions
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
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.
Interventions
DRUGDexamethasone
10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Temporal changes in leukemic cell NF-kB activity | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate | 5 years |
| Apoptosis related to NF-kB modulation | 5 years |
Countries
United States
Outcome results
None listed