oblimersen and gemtuzumab ozogamicin in treating older patients with relapsed acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug. purpose: phase ii trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.

objectives: * determine the complete response rate of elderly patients with relapsed cd33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin. * determine the overall response rate and duration of response of patients treated with this regimen. * determine the safety of this regimen in these patients. outline: this is a multicenter study. patients receive oblimersen iv continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin iv over 2 hours on days 4 and 18. patients are followed monthly for 6 months. projected accrual: a total of 20-100 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed cd33+ acute myeloid leukemia (aml) * in first relapse from chemotherapy * complete response lasting at least 3 months before relapse * no cns leukemia * no secondary leukemia or history of antecedent hematologic disorder prior to initial onset of aml (e.g., myelodysplasia) patient characteristics: age: * 60 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * wbc less than 30,000/mm\^3 * no bleeding or coagulation disorder except disease-related disseminated intravascular coagulation hepatic: * bilirubin no greater than 1.5 mg/dl * pt and ptt no greater than 1.5 times upper limit of normal or * inr no greater than 1.3 * no history of chronic hepatitis or cirrhosis renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no uncontrolled congestive heart failure * no new york heart association class iii or iv heart disease pulmonary: * no severe pulmonary disease other: * hiv negative * no other concurrent medical disease that would preclude study entry * no known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, e. coli protein, or any product produced in e. coli * no other concurrent malignancy * no known human anti-human antibodies * no uncontrolled seizure disorder * no active uncontrolled infection * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior allogeneic or autologous stem cell transplantation * no prior therapy with an anti-cd33 antibody (e.g., gemtuzumab ozogamicin or m195) chemotherapy: * see disease characteristics * at least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea endocrine therapy: * not specified radiotherapy: * at least 2 weeks since prior systemic radiotherapy surgery: * at least 2 weeks since prior major surgery * no prior organ allograft other: * at least 3 weeks since prior antileukemic therapy and recovered * no other concurrent investigational therapy * no concurrent immunosuppressive therapy

Keywords: recurrent adult acute myeloid leukemia