Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.

Detailed Description
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OBJECTIVES: Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia. Determine the toxicity of this vaccination in these patients. OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks. Patients are followed for 2 weeks.

Official Title
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A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase

Conditions
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Leukemia

Intervention / Treatment
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* Biological: recombinant 70-kD heat-shock protein


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myelogenous leukemia Philadelphia chromosome positive Peripheral blast count no greater than 10% No molecular remission Less than 3 years since initial diagnosis No anticipation of requirement for bone marrow or stem cell transplantation for 6 months PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL Platelet count at least 20,000/mm^3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) Transaminase less than 2.0 times ULN Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No significant active infection requiring hospitalization No other serious illness or significant behavioral or psychological problem that would preclude study involvement PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior interferon alfa allowed No concurrent interferon alfa Chemotherapy: Prior cytarabine or other cytotoxic agents allowed No concurrent cytarabine or other cytotoxic agents Concurrent hydroxyurea allowed Endocrine therapy: No concurrent corticosteroid therapy Radiotherapy: Not specified Surgery: Not specified Other: No concurrent immunosuppressive medications Concurrent imatinib mesylate allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br>recombinant 70-kD heat-shock protein | Biological: recombinant 70-kD heat-shock protein<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive