Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)
- Determine the clinical responses in patients with HLA-A0201-positive refractory
metastatic melanoma treated with tyrosinase-related protein-2:180-188 peptide vaccine
- Determine the clinical response rate of patients who have an immediate need to receive
interleukin-2 (IL-2) in addition to this vaccine.
- Compare the immunologic response, in terms of changes in T-cell precursors before and
after treatment, in patients treated with this vaccine with or without IL-2.
- Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a randomized, open-label study.
Patients who need immediate interleukin-2 (IL-2) receive tyrosinase-related protein-2
(TRP-2):180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2
IV over 15 minutes once every 8 hours on days 2-5. Treatment repeats every 3 weeks for up to
4 courses in the absence of disease progression or unacceptable toxicity.
Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51
subcutaneously (SC) on day 1. Treatment repeats every 3 weeks for up to 4 courses in
the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51
SC once weekly on weeks 1-4. Treatment repeats every 7 weeks for up to 4 courses in the
absence of disease progression or unacceptable toxicity.
Patients who have a complete response (CR) receive 1 additional course after achieving CR.
Patients who have progressive disease while receiving vaccine alone may cross over to
receive peptide vaccine with IL-2 for at least 2 courses.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A maximum of 83 patients (19-33 who need immediate interleukin-2 (IL-2);
15-25 per treatment arm who do not need immediate IL-2) will be accrued for this study
within 1 year.
Allocation: Randomized, Masking: Open Label, 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|