Leukemia
Conditions
Keywords
recurrent adult acute myeloid leukemia
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate, dexamethasone, and sargramostim in treating patients who have refractory or relapsed acute myeloid leukemia.
Detailed description
OBJECTIVES: * Determine the objective response (complete hematologic remission induction) of phenylbutyrate, dexamethasone, and sargramostim (GM-CSF) in patients with refractory or relapsed t(8;21) acute myeloid leukemia. * Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen. * Determine the overall survival of patients on this regimen. * Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients. * Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive phenylbutyrate IV continuously and sargramostim (GM-CSF) subcutaneously on days 1-7 and 15-21. Patients also receive oral dexamethasone on days 1-4 and 15-18. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity until complete hematologic remission is induced. Patients with stable disease at the end of 1 course receive at least 2 additional courses. Patients are followed twice a week for 3 months, monthly for 1 year, every three months for the next 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study in at least 2 years.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of t(8;21) acute myeloid leukemia (AML) * Failed standard induction chemotherapy or stem cell transplantation (SCT) OR * Relapsed after standard induction chemotherapy or SCT OR * Refused or not a candidate for SCT or matched allogeneic sibling bone marrow transplantation or donor lymphocyte infusion OR * Refused of not a candidate for autologous SCT or bone marrow transplantation * No CNS leukemia PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 7 days Hematopoietic: * Not specified Hepatic: * AST or ALT no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than 3 times ULN * No hepatic disease that would preclude study Renal: * Creatinine no greater than 2 mg/dL * Creatinine clearance at least 60 mL/min * No renal disease that would preclude study Cardiovascular: * No cardiac disease that would preclude study * No New York Heart Association class III or IV heart disease * No myocardial infarction within past 8 weeks Other: * No active infection except cystitis * Not pregnant or nursing * No altered mental status or seizure disorder * No other serious disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 3 weeks since prior investigational antineoplastic drugs
Countries
United States
Outcome results
None listed