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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QS21
bcr-abl peptide vaccine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
June 24, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004052
Brief Title
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Official Title
Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
QS21
Intervention Type
Biological
Intervention Name(s)
bcr-abl peptide vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Cathcart, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

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