Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2012-04-01
• 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.

PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Asparaginase; Cortisol succinate; Cytarabine; Daunorubicin; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methotrexate; Thioguanine

Criteria

DISEASE CHARACTERISTICS:

• Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML)

• Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test

• Trisomy 21 mosaicism allowed

• Group I:

• Diagnosis of TMD in patients no older than 90 days at initial presentation

• Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following:

• Verification with a second sample

• More than 5% bone marrow blasts

• Hepatomegaly and/or splenomegaly

• Lymphadenopathy

• Cardiac or pleural effusions OR

• Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal)

• Bone marrow aspirate is required

• Group II (closed to accrual as of 6/24/04):

• Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies:

• Refractory anemia (RA)

• RA with excess blasts (RAEB)

• RAEB in transformation

• RA with ringed sideroblasts (RARS)

• Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following:

• Absolute neutrophil count less than 500/mm^3

• Untransfused platelet count less than 30,000/mm^3

• Untransfused hemoglobin less than 8 g/dL

• The following diagnoses will be observed only:

• RA with mild cytopenias*

• RARS with mild cytopenias*

• Mild primary cytopenias (one or more) without dysplasia (confirmed by hypoplastic bone marrow exam) NOTE: * Platelet count 30-150,000/mm3, absolute neutrophil count 500-1,499/mm3, and hemoglobin greater than 8 g/dL

• Granulocytic sarcoma (chloroma), with or without bone marrow involvement, allowed

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

• 21 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• See Disease Characteristics

Renal:

• Not specified

Cardiovascular:

• Shortening fraction greater than 27% by echocardiogram* OR

• Ejection fraction greater than 47% by radionuclide angiogram* NOTE: *For patients with MDS and AML (as of 2/24/04, previously diagnosed MDS or AML closed to accrual; MDS or AML that develops (secondary to TMD) after study enrollment or MDS that requires initial observation [with or without subsequent treatment] allowed)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy for TMD allowed

• No prior chemotherapy for malignancy

Endocrine therapy:

• Concurrent topical or inhaled steroids for other conditions allowed

Radiotherapy:

• No prior radiotherapy for malignancy

Surgery:

• Not specified

Other:

• No prior antileukemic therapy

• Prior enrollment on this study for TMD allowed