Leukemia
Conditions
Keywords
recurrent adult acute myeloid leukemia
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALoblimersen sodium
DRUGgemtuzumab ozogamicin
Sponsors
Genta Incorporated
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed