Leukemia Clinical Trial
Official title:
A Pilot Study of Phenylbutyrate, Dexamethasone and GM-CSF in Refractory or Relapsed t(8;21) Acute Myeloid Leukemia
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.
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.
;
Primary Purpose: Treatment
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