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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

Phase 2
56 Years
Not Enrolling

Thank you

Trial Information

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

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) No M3 AML
or blastic phase chronic myelogenous leukemia Must be registered on protocols SWOG-9007
and SWOG-9910

PATIENT CHARACTERISTICS: Age: 56 and over Performance status: Zubrod 0-3 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times
upper limit of normal (ULN) SGOT/SGPT no greater than 4 times ULN Renal: Creatinine no
greater than 1.5 times ULN Creatinine clearance greater than 40 mL/min Cardiovascular:
LVEF at least 50% by MUGA or echocardiogram No unstable cardiac arrhythmias or angina
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
malignancy within the past 5 years except: Adequately treated basal cell or squamous cell
skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in
complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for acute leukemia Prior hydroxyurea to control high cell counts allowed At
least 30 days since prior low dose cytarabine (less than 100 mg/m2/day) for
myelodysplastic syndrome and recovered Single dose of prior or concurrent (with induction
chemotherapy) intrathecal chemotherapy allowed Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

after induction therapy is completed

Safety Issue:


Principal Investigator

Thomas R. Chauncey, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Veterans Affairs


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

March 2006

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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