Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: Amifostine; Cytarabine; Idarubicin

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed acute myeloid leukemia (AML)

• M0-M2, M4-M7

• Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood)

• M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid

• Evaluable disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• Ejection fraction at least 50%

• Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration

Other:

• No preexisting severe organ dysfunction

• No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study

• Not pregnant or nursing

• Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior cytotoxic therapy for AML

• No prior amifostine

• At least 1 month since chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since radiotherapy

Surgery:

• Not specified