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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00004052
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : June 25, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Biological: QS21 Biological: bcr-abl peptide vaccine Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia.
  • Determine the antileukemic effects of vaccination with these peptides in these patients.

OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
Study Start Date : March 1999
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven chronic myelogenous leukemia

    • Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint
    • No accelerated or blastic phase
  • Must be in hematologic remission with peripheral WBC less than 20,000/mm^3

PATIENT CHARACTERISTICS:

Age:

  • Over 16

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Absolute granulocyte count greater than 1,200/mm^3
  • Platelet count greater than 70,000/mm^3
  • Hemoglobin greater than 9.0 g/dL
  • No active bleeding

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • Lactate dehydrogenase less than 2 times normal

Renal:

  • Creatinine less than 2.0 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • No uncontrolled active infection requiring antibiotics
  • No other serious illness
  • No immunodeficiency other than from prior bone marrow transplantation
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 months since prior allogeneic or autologous bone marrow transplantation
  • Prior vaccination with pentavalent peptide at less than study dose level allowed
  • At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine
  • Concurrent interferon allowed

Chemotherapy:

  • At least 2 weeks since prior low-dose subcutaneous cytarabine
  • At least 4 weeks since prior chemotherapy other than hydroxyurea
  • No concurrent chemotherapy except hydroxyurea

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • No concurrent surgery

Other:

  • Concurrent imatinib mesylate allowed
  • No other concurrent systemic therapy
Contacts and Locations
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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): NCT00004052


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Kathleen Cathcart, MD Memorial Sloan Kettering Cancer Center
More Information
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ClinicalTrials.gov Identifier: NCT00004052    
Other Study ID Numbers: 99-012
CDR0000067247 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-H99-0036
First Posted: May 8, 2003    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases