Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00004052|
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : June 25, 2013
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|
- 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|
|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|
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|