Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute promyelocytic leukemia (M3), refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, de novo myelodysplastic syndromes, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, blastic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Acute myeloid leukemia meeting 1 of the following criteria: Previously untreated and not a candidate for anthracycline-based chemotherapy In first or second relapse or refractory Secondary to chemotherapy or an antecedent hematologic disorder and treated with no more than 1 prior intensive induction regimen Chronic myelogenous leukemia in blast crisis at diagnosis or after prior imatinib mesylate Myelodysplastic syndromes (MDS) Refractory anemia with excess blasts (RAEB) or RAEB in transformation Must meet at least 1 of the following criteria: Absolute neutrophil count no greater than 500/mm^3 Platelet or red cell transfusion-dependent after no more than 1 prior intensive induction chemotherapy Acute promyelocytic leukemia t(15, 17) Failed prior treatment with tretinoin and arsenic Relapsed disease at least 3 months after prior autologous stem cell transplantation No active CNS leukemia PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy At least 8 weeks Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal Renal Creatinine clearance at least 50 mL/min Cardiovascular Ejection fraction at least 40% No poorly controlled cardiac disease Pulmonary No poorly controlled pulmonary disease Other Not pregnant or nursing Negative pregnancy test Fertile female patients must use 1 highly effective and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study Male patients must use effective contraception during and for 4 weeks after study Willing and able to comply with the System for Thalidomide Education and Prescribing Safety (STEPS) program HIV negative No poorly controlled infection No other active malignancy No severe peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Prior thalidomide allowed for MDS At least 5 days since prior hematopoietic growth factors At least 2 weeks since prior biologic therapy No prior allogeneic bone marrow transplantation Chemotherapy See Disease Characteristics At least 24 hours since prior hydroxyurea Endocrine therapy At least 24 hours since prior corticosteroids Radiotherapy Not specified Surgery Not specified Other At least 2 weeks since prior cytotoxic anticancer therapy Prior amifostine allowed for MDS
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center