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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004052
  Purpose

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 Intervention Phase
Leukemia
Drug: QS21
Drug: bcr-abl peptide vaccine
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   QS 21   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine

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

Estimated Enrollment:   24
Study Start Date:   March 1999

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004052

Locations
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
Study Chair:     Kathleen Cathcart, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000067247, MSKCC-99012, NCI-H99-0036
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004052
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  

Study placed in the following topic categories:
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
QS 21
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008




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