Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia

PRIMARY OBJECTIVES:

I. To evaluate the toxicity and overall survival of high dose Bu (busulfan)/VP-16 (etoposide) followed by post-transplant low-dose interleukin (IL)-2 (aldesleukin) in patients with AML.

SECONDARY OBJECTIVES:

I. To estimate the rate of relapse associated with this regimen.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive busulfan intravenously (IV) over 2 hours or orally (PO) every 6 hours on days -7 to -4 and etoposide IV on day -3.

STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.

POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin subcutaneously (SC) daily for 12 weeks.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Inclusion criteria

• The patient must have AML that falls into one of the following categories:
• AML in 1st complete remission (CR) with intermediate or high risk of relapse following conventional therapy; at least, one of the following features is needed:

• Patient required more than one cycle of induction to achieve first CR
• White blood cell count (WBC) > 100,000/mm^3 at diagnosis
• Any of the following cytogenetic abnormalities: inv (3), t(3:3), del (5q) or -5, 11q23, del(7q) or -7, del (20q) or -20, abnormal 12p, +11 or t8
• Any other abnormalities or combination of abnormalities which would predict intermediate or high risk of relapse
• AML beyond first CR
• Any patient with an identical twin donor who also meets the criteria above
• Patients with AML in 1st CR should receive at least two cycles of consolidation chemotherapy prior to mobilization and transplant
• Patients must have an adequate number of stem cells previously collected (i.e., > 2 x 10^8 total nucleated cell [TNC] of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg, unless approved otherwise by Dr. Holmberg); prior to stem cell collection patients must be documented to be in remission and to have received two cycles of consolidation therapy after induction therapy
• Pre-Study tests have been performed
• Patient must sign an institutional review board (IRB) approved informed consent, conforming with federal and institutional guidelines

Exclusion criteria

• Patients with good risk AML defined by cytogenetic evaluation with these abnormalities: inversion 16 or t8;21
• Patient's life expectancy is severely limited by diseases other than AML
• Patient is human immunodeficiency virus (HIV) seropositive
• Patient is pregnant
• Patient's creatinine > 2.0 mg/dl
• Patient's total bilirubin > 2.0 mg/dl (unless Gilbert's disease)
• Or serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) >= 2.5 x upper limit of normal (ULN) not due to leukemia
• Patient has a history of congestive heart failure, uncontrolled arrhythmias or left ventricular ejection fraction (LVEF) < 50%
• Patient has an unrelated human leukocyte antigen (HLA) matched donor and is eligible for a higher priority Fred Hutchinson Cancer Research Center (FHCRC) protocol (for FHCRC patients only)
• Patient has an HLA matched or one antigen mismatch family donor available
• Patients with a significant active infection that precludes transplant
• Patients with a Karnofsky Performance Score less than 70