Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Farmington, Connecticut 06030


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00030303


Primary Contact:

Study Chair
Zihai Li, MD, PhD
University of Connecticut Health Center


Backup Contact:

N/A


Location Contact:

Farmington, Connecticut 06030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.