A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
OBJECTIVES:
- Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and
sargramostim (GM-CSF) in patients with sarcoma or brain tumor.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the frequency of T-cell specific vaccine antigens during and after
administration of this regimen in these patients.
- Determine, preliminarily, the clinical response, if any, of patients treated with this
regimen.
OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3
and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23.
PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for
this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
W. Nicholas Haining, BM, BCh
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
03-365
NCT00069940
December 2000
August 2008
Name | Location |
---|---|
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |