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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UConn Health
ClinicalTrials.gov Identifier:
NCT00030303
First received: February 14, 2002
Last updated: April 26, 2017
Last verified: April 2017
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
UConn Health
Investigators
Study Chair: Zihai Li, MD, PhD UConn Health
  More Information

Publications:
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.

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
Study First Received: February 14, 2002
Last Updated: April 26, 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

ClinicalTrials.gov processed this record on September 18, 2017