Overview

Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia

Status:
Completed

Trial end date:
2007-03-01

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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Children's Oncology Group

Collaborator:

National Cancer Institute (NCI)

Treatments:

Asparaginase
Cytarabine
Daunorubicin
Lenograstim
Melphalan
Sargramostim
Thioguanine

Criteria

DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid
leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with
cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there
is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR
unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down
syndrome

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3
times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no
greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary:
No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis
or meningitis Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy