Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Study Overview
=================
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.

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

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Biological: QS21
* Biological: bcr-abl peptide vaccine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: QS21|nan|
|Biological: bcr-abl peptide vaccine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia