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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Chair: | Kathleen Cathcart, MD | Memorial Sloan Kettering Cancer Center |
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 |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |