Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

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

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, Senior)
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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00004052 History of Changes
Other Study ID Numbers:	99-012; CDR0000067247 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-H99-0036
First Posted:	May 8, 2003
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:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders	Bone Marrow Diseases; Hematologic Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs