This trial is active, not recruiting.

Condition leukemia
Treatment recombinant 70-kd heat-shock protein
Phase phase 1
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).