Trial Information

Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon

OBJECTIVES: I. Assess the efficacy of high dose cytarabine with mitoxantrone and amifostine
as induction therapy for patients with previously untreated standard risk acute myelogenous
leukemia (AML). II. Assess the effects of amifostine on the biology of AML cells in vivo in
these patients. III. Determine whether there is a relationship between cytokine production
before and during remission induction therapy and treatment outcome.

OUTLINE: Prior to treatment, patients undergo bone marrow aspirate and biopsy. On day -3,
patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow
aspirate and biopsy. Patients then receive amifostine IV over 5-7 minutes on the same day.
Prior to chemotherapy on day 1, patient receive broxuridine IV over 60 minutes immediately
followed by bone marrow aspirate and biopsy. Chemotherapy on day 1 consists of amifostine
followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1
hour immediately after the second infusion of cytarabine. This course is repeated on day 5
after another bone marrow biopsy and aspirate. Starting on day 6, patients receive
amifostine 3 times a week until day 28 or beyond. Patients who respond to treatment continue
on to receive three courses of consolidation therapy. Consolidation courses 1 and 3 consist
of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1, 2, and
3. Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours
for 4 days. Twenty-four hours after each course of consolidation therapy, patients receive
isotretinoin orally every day and interferon alfa subcutaneously every other day.
Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next
course of consolidation therapy. Following recovery from course 3 of consolidation therapy,
patients continue to receive isotretinoin/interferon alfa until relapse. Patients in
complete remission after the 3 courses of consolidation therapy receive
isotretinoin/interferon alfa for 3 years. Patients are followed every 3 months for the first
year, then every 6 months for the next 2 years.

PROJECTED ACCRUAL: There will be 40-45 patients accrued into this study.