Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
- Determine whether an immunologic response can be obtained in HLA*0201-expressing
patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine
emulsified in Montanide ISA-51.
- Determine which vaccine strategy (frequency, schedule, and dosing) is best for future
studies in these patients.
- Determine the toxicity of this treatment in these patients.
- Determine whether prior immunization with telomerase: 540-548 peptide vaccine results
in increased clinical response to interleukin-2 in patients with melanoma.
OUTLINE: This is a randomized study. Patients are stratified according to disease
(metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of
three treatment arms.
- Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo
leukapheresis over 3 hours at baseline and after each course of treatment.
- Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3
hours at baseline, after the vaccine on week 4, and after each course of treatment.
- Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease
progression or unacceptable toxicity. Patients with a complete response (CR) receive 1
additional course of treatment after achieving CR.
Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms
may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after
each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on
weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease
progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum)
will be accrued for this study within less than 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|