Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

UConn Health20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

recombinant 70-kD heat-shock proteinBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Connecticut Health Center

Farmington, Connecticut, United States

Data from ClinicalTrials.gov

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