Oblimersen and Gemtuzumab Ozogamicin 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
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
Sites / Locations
- Genta Incorporated