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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004052 |
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 |
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Leukemia |
Biological: QS21 Biological: bcr-abl peptide vaccine |
Phase II |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | March 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven chronic myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000067247, MSKCC-99012, NCI-H99-0036 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004052 History of Changes |
Health Authority: | United States: Federal Government |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia |
Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid QS 21 Bone Marrow Diseases |
Leukemia Neoplasms Neoplasms by Histologic Type Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |