Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine

Date de début de l'étude : 1 mars 1999

DISEASE CHARACTERISTICS: Histologically proven chronic myelogenous leukemia Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint No accelerated or blastic phase Must be in hematologic remission with peripheral WBC less than 20,000/mm^3 PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Absolute granulocyte count greater than 1,200/mm^3 Platelet count greater than 70,000/mm^3 Hemoglobin greater than 9.0 g/dL No active bleeding Hepatic: Bilirubin less than 2.0 mg/dL Lactate dehydrogenase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled active infection requiring antibiotics No other serious illness No immunodeficiency other than from prior bone marrow transplantation Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior allogeneic or autologous bone marrow transplantation Prior vaccination with pentavalent peptide at less than study dose level allowed At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine Concurrent interferon allowed Chemotherapy: At least 2 weeks since prior low-dose subcutaneous cytarabine At least 4 weeks since prior chemotherapy other than hydroxyurea No concurrent chemotherapy except hydroxyurea Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: No concurrent surgery Other: Concurrent imatinib mesylate allowed No other concurrent systemic therapy