Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
Eligibility Criteria
DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate More than 20% blasts by morphologic criteria Relapsed disease ≥ 3 months after prior complete remission Blasts CD33-positive by flow cytometry No primary hematologic disorder that preceded initial presentation with AML No documented secondary AML related to prior chemotherapy or toxin exposure No acute promyelocytic leukemia (FAB M3) Not a candidate for transplant therapy No active CNS leukemia PATIENT CHARACTERISTICS: Age 60 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC ≤ 30,000/mm^3 (hydroxyurea allowed) Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 mg/dL Other HIV negative No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy Not planning hematopoietic stem cell transplantation immediately after study therapy Chemotherapy See Disease Characteristics See Hematopoietic Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 1 month since prior investigational agents No other concurrent anticancer therapy No administration of any of the following for 24 hours after cyclosporine administration: Diltiazem Verapamil Erythromycin Clarithromycin Metoclopramide Phenytoin Rifampin Phenobarbital Aminoglycosides Amphotericin B Vancomycin Cimetidine Ranitidine Trimethoprim/sulfamethoxazole Ketoconazole Fluconazole Itraconazole Voriconazole Carbamazepine
Sites / Locations
- Fred Hutchinson Cancer Research Center