Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
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.
Interventional
Primary Purpose: Treatment
Kathleen Cathcart, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
99-012
NCT00004052
March 1999
August 2005
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |