Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
This trial is active, not recruiting.
|Treatment||recombinant 70-kd heat-shock protein|
|Sponsor||University of Connecticut Health Center|
|Start date||January 2001|
|Trial identifier||NCT00030303, CDR0000069127, NCI-V01-1685, UCHC-01117, UCHC-7659|
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.
Male or female participants at least 18 years old.
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
|Official title||A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase|
|Description||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. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.|
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