Overview

Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Status:
Completed
Trial end date:
2008-06-01
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 more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cladribine
Cobalt
Cortisol succinate
Cytarabine
Etoposide
Etoposide phosphate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Lenograstim
Methotrexate
Mitoxantrone
Criteria
DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) or myelodysplastic syndrome in one of
the following categories: In first relapse Failed to achieve initial complete remission
Newly diagnosed secondary AML eligible Required bone marrow status: Greater than 25% blasts
(M3) OR Persistent abnormal clone on cytogenetics and 5-25% blasts (M2) No Fanconi's anemia

PATIENT CHARACTERISTICS: Age: Under 22 Performance status: Not specified Hematopoietic: See
Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times normal AST or ALT less
than 4.0 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine
clearance or GFR greater than 70 mL/min per 1.73 square meters or GFR in equivalent
institutional normal range Cardiovascular: Shortening fraction greater than 27% by
echocardiogram or in institutional normal range OR Ejection fraction greater than 47% by
radionuclide angiogram

PRIOR CONCURRENT THERAPY: No more than 1 prior treatment No prior salvage therapy No prior
mitoxantrone