High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Aldesleukin; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Idarubicin; Interleukin-2; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven de novo or secondary acute myeloid leukemia with a classification of M0-M2 or M4-M7

• No classification of M3

• No promyelocytic leukemia

• Prior medical conditions allowed:

• Myelodysplastic syndromes

• Aplastic anemia

• Paroxysmal nocturnal hemoglobinuria

• Myeloproliferative disorders except Philadelphia chromosome positive chronic myelogenous leukemia

PATIENT CHARACTERISTICS:

Age:

• Over 25

Performance status:

• Not specified

Life expectancy:

• At least 4 weeks

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2 times normal

• SGOT no greater than 2 times normal

• Alkaline phosphatase no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Cardiovascular:

• Ejection fraction at least 45%

• No severe cardiovascular disease including myocardial infarction within past 6 months, uncontrolled symptomatic congestive heart failure, angina pectoris, or multifocal cardiac arrhythmias

Other:

• No uncontrolled diabetes mellitus

• No other active malignancy

• No hypersensitivity to E. coli derived drug preparations

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for acute leukemia except hydroxyurea

• Prior chemotherapy allowed for other malignancy or other medical condition

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed for other malignancy or other medical condition

Surgery:

• Not specified