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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002800 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Neutropenia |
Biological: filgrastim Biological: lintuzumab Drug: cytarabine Drug: etoposide Drug: idarubicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 1996 |
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Peter Maslak, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000064897, MSKCC-96044, NCI-V96-0941 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002800 History of Changes |
| Health Authority: | United States: Federal Government |
|
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia untreated adult acute myeloid leukemia refractory anemia with excess blasts |
refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia de novo myelodysplastic syndromes neutropenia |
|
Antimetabolites Anti-Infective Agents Blast Crisis Chronic Myelomonocytic Leukemia Immunologic Factors Precancerous Conditions Leukocyte Disorders Leukemia, Myeloid, Acute Etoposide phosphate Granulocytopenia Refractory Anemia Anti-Bacterial Agents Leukemia Preleukemia Acute Myelocytic Leukemia |
Anemia, Refractory Acute Myeloid Leukemia, Adult Etoposide Cytarabine Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Agranulocytosis Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Neutropenia Idarubicin |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukocyte Disorders Antibiotics, Antineoplastic Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome |
Cytarabine Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Agranulocytosis Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neutropenia Neoplasms Idarubicin Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
