A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
- Determine whether amifostine provides systemic protection against the nonhematologic
side effects of idarubicin (IDR) during induction therapy of acute myeloid leukemia
(AML), allowing the dose of idarubicin to be escalated.
- Determine the maximum tolerated dose of idarubicin when amifostine is used as a
- Determine the incidence and severity of dose limiting hypotension in patients receiving
amifostine and the ability to offset this side effect with vasoconstrictive agents.
- Determine whether any additional side effects of amifostine are dose limiting in
patients with AML treated with IDR and cytarabine (ARA-C).
- Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving
enteric pathogens in these patients.
- Determine the requirement for intravenous hyperalimentation in patients receiving
amifostine, IDR, and ARA-C.
OUTLINE: This is a dose escalation study of idarubicin (IDR).
Patients receive amifostine IV over 15 minutes, followed 15-30 minutes later by
chemotherapy. Idarubicin IV is administered over 15 minutes on days 1-3. Cytarabine is
administered by continuous infusion on days 1-7. Patients may receive 1 additional course of
treatment, if necessary.
Cohorts of 3-6 patients each are treated at each dose level of idarubicin. Dose escalation
is discontinued when 2 or more patients experience dose limiting toxicity.
Patients are followed at 3 months.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Primary Purpose: Treatment
Neal Flomenberg, MD
Kimmel Cancer Center (KCC)
United States: Federal Government
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|