Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00004052
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States