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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00030303
First Posted: January 27, 2003
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UConn Health
  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 Biological: recombinant 70-kD heat-shock protein Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase

Resource links provided by NLM:


Further study details as provided by UConn Health:

Enrollment: 20
Actual Study Start Date: January 2001
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccine
recombinant 70-kD heat-shock protein
Biological: recombinant 70-kD heat-shock protein

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030303


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

Publications:
Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00030303     History of Changes
Other Study ID Numbers: UCHC-01117
CDR0000069127 ( Registry Identifier: PDQ (Physician Data Query) )
UCHC-7659
NCI-V01-1685
First Submitted: February 14, 2002
First Posted: January 27, 2003
Last Update Posted: April 28, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UConn Health:
chronic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases