Leukemia Clinical Trial
Official title:
A Phase II Study of Daunomycin and ARA-C Given by Continuous IV Infusion With PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by
making them more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine
in treating older patients who have newly diagnosed acute myeloid leukemia.
OBJECTIVES: I. Determine the safety and efficacy of daunorubicin and cytarabine by
continuous infusion and PSC 833 in patients over age 56 with newly diagnosed acute myeloid
leukemia. II. Determine the frequency and severity of toxicities of this regimen in these
patients. III. Determine the frequency and prognosis of functional and phenotypic
P-glycoprotein expression, cytogenetics, and pharmacokinetics in this population.
OUTLINE: This is a multicenter study. Patients receive induction chemotherapy consisting of
PSC 833 IV over 2 hours on day 1, then continuously for 96 hours; daunorubicin IV
continuously on days 1-3; and cytarabine IV continuously on days 1-7. Filgrastim (G-CSF) or
sargramostim (GM-CSF) is administered subcutaneously (SQ) or IV beginning on day 15 and
continuing until blood counts recover or day 21. If patients do not achieve complete
remission after one course, a second course is administered. Patients who achieve A1 bone
marrow, B1 peripheral blood, and C1 extramedullary disease status after 1 or 2 courses of
induction chemotherapy proceed to consolidation therapy, which begins upon recovery from
induction therapy. Consolidation therapy consists of PSC 833 over 2 hours on day 1,
daunorubicin IV over 1-5 minutes on days 1 and 2, and cytarabine IV continuously on days
1-5. Treatment repeats for a total of 2 courses. Patients are followed every 6 months for 2
years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 8-9
months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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