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 high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.

Condition	Treatment or Intervention	Phase
accelerated phase chronic myelogenous leukemia untreated adult acute myeloid leukemia de novo myelodysplastic syndrome refractory anemia with excess blasts in transformation refractory anemia with excess blasts Neutropenia Chronic Myelomonocytic Leukemia blastic phase chronic myelogenous leukemia	Drug: cytarabine  Drug: etoposide  Drug: filgrastim  Drug: idarubicin  Drug: monoclonal antibody HuG1-M195	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease.

PROTOCOL OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival.

PROJECTED ACCRUAL: 60 patients will be entered over 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia
• Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia
• Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy; RAEB in transformation; Chronic myelomonocytic leukemia
• No acute promyelocytic leukemia

--Prior/Concurrent Therapy--

• No prior therapy except biologic agent alone or hydroxyurea

--Patient Characteristics--

• Age: 18 and over
• Performance status: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 2.0 mg/dL; Transaminases no greater than 3 times normal
• Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min
• Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure
• Other: No concurrent active malignancy; No pregnant or nursing women

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Peter Maslak,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000064897; MSKCC-96044; NCI-V96-0941
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002800
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08