Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 30, 1996

Primary Completion Date

February 28, 2003

Study Completion Date

March 31, 2009

Conditions
Leukemia
Interventions
BIOLOGICAL

filgrastim

10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed

DRUG

busulfan

1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.

DRUG

cytarabine

2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4

DRUG

etoposide

40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant

DRUG

methotrexate

For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation

PROCEDURE

peripheral blood stem cell transplantation

Infusion on Day 0

Trial Locations (3)

21201

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore

94115-0128

UCSF Cancer Center and Cancer Research Institute, San Francisco

07503

St. Joseph's Hospital and Medical Center, Paterson

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER