Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030303
• Other study ID #: UCHC-01117
• Secondary ID: CDR0000069127UCH
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2002
• Last updated: April 26, 2017
• Start date: January 2001
• Est. completion date: January 2004

Study information

• Verified date: April 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Biological:
• recombinant 70-kD heat-shock protein

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Li Z, Qiao Y, Laska E, et al.: Combination of imatinib mesylate with autologous leukocyte-derived heat shock protein 70 vaccine for chronic myelogenous leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-664, 2003.