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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00004052
First received: December 10, 1999
Last updated: June 24, 2013
Last verified: June 2013

December 10, 1999
June 24, 2013
March 1999
August 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004052 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Biological: QS21
  • Biological: bcr-abl peptide vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2005
August 2005   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004052
99-012, CDR0000067247, NCI-H99-0036
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Kathleen Cathcart, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP