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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
Sponsored by: University of Connecticut
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030303
  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.


Condition Intervention Phase
Leukemia
Drug: recombinant 70-kD heat-shock protein
Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030303

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1601
Sponsors and Collaborators
University of Connecticut
Investigators
Study Chair: Zihai Li, MD, PhD University of Connecticut
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Study ID Numbers: CDR0000069127, UCHC-01117, UCHC-7659, NCI-V01-1685
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030303  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009