Overview
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Status:
Completed
Completed
Trial end date:
2008-06-01
2008-06-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Oncology GroupCollaborator:
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 ofthe 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