Leukemia Clinical Trial
Official title:
A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of
chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with
newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.
OBJECTIVES:
- 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
chemotherapy protectant.
- 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
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