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.

Condition	Treatment or Intervention	Phase
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia	Drug: heat shock protein 70  Procedure: biological response modifier therapy  Procedure: tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06030-1601,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000069127; UCHC-01117; UCHC-7659; NCI-V01-1685
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030303
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08