Leukemia
Conditions
Keywords
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.
Detailed description
OBJECTIVES: * Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia. * Determine the antileukemic effects of vaccination with these peptides in these patients. OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Interventions
BIOLOGICALbcr-abl peptide vaccine
BIOLOGICALQS21
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed