Phase I Study Of Telomerase Peptide Vaccination For Patients With Advanced Breast Cancer
- Determine the safety of telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 and sargramostim (GM-CSF) in patients with HLA-A2-expressing stage IV breast
- Compare the generation of human telomerase reverse transcriptase (hTERT)
peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte (CTL)
immunity in patients treated with this regimen.
- Correlate the dose level of this regimen with the generation of hTERT-specific CTL
immunity and the development of hTERT-specific autoimmunity in these patients.
- Determine the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of the telomerase: 540-548 peptide and CMV 495
peptide portions of the vaccine.
Patients receive telomerase: 540-548 peptide and CMV 495 peptide (as an immunological
control) vaccine emulsified in Montanide ISA-51 subcutaneously (SC) followed by sargramostim
(GM-CSF) SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, and 27 (for a total of 8
vaccinations). Treatment continues in the absence of disease progression or unacceptable
Cohorts of 5-8 patients receive escalating doses of telomerase: 540-548 peptide and CMV 495
peptide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity. A total
of 12 patients receive treatment at the MTD.
Patients are followed within 30 days and then at 6 and 12 months.
PROJECTED ACCRUAL: A total of 5-28 patients will be accrued for this study.
Primary Purpose: Treatment
Susan Domchek, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|