Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

UConn Health

Status and phase: Completed; Phase 1

Conditions: Leukemia

Treatments: Biological: recombinant 70-kD heat-shock protein

Study type: Interventional

Funder types: Other

Identifiers

NCT00030303

NCI-V01-1685

CDR0000069127 (Registry Identifier)

UCHC-01117

UCHC-7659

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

vaccine

Experimental group

Description:

recombinant 70-kD heat-shock protein

Treatment:

Biological: recombinant 70-kD heat-shock protein