NCT00004217

S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 56 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 μg/kg/day IV or SC
BIOLOGICAL	sargramostim	5 μg/kg/day IV or SC starting d 15
DRUG	cytarabine	Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833
DRUG	daunorubicin hydrochloride	continuous IV: Hours 2 - 74 before PSC-833
DRUG	valspodar	2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96

Timeline

• Start date: 2000-02-01
• Primary completion: 2001-05-01
• Completion: 2006-03-01
• First posted: 2004-06-18
• Last updated: 2015-03-06

Locations

90 sites across 2 countries: United States, Canada