Myeloproliferative Neoplasms Clinical Trial
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
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.
Full 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.
Eligibility 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
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There are 2 Locations for this study
New York New York, 10021, United States
Houston Texas, 77030, United States
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