Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
- Determine the maximum tolerated dose and recommended dose of sargramostim (GM-CSF)
plasmid DNA adjuvant with a multi-epitope peptide vaccine comprising tyrosinase peptide
and gp100 antigen in patients with stage IIB, IIC, III, or IV melanoma who are
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine the immunogenicity of this regimen in these patients.
- Determine any anti-tumor response in patients treated with this regimen.
OUTLINE: This is a phase I, pilot, dose-escalation study of sargramostim (GM-CSF) plasmid
DNA adjuvant followed by a phase II, pilot study.
- Phase I: Patients receive GM-CSF plasmid DNA adjuvant subcutaneously (SC) on day 1 and
a vaccine comprising tyrosinase peptide and gp100 antigen SC on day 5. Treatment
repeats every 28 days for a total of 3 courses in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of GM-CSF plasmid DNA adjuvant until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive vaccination as in phase I at the MTD. After completion of
study, patients are followed up for 1 year.
PROJECTED ACCRUAL: A total of 3-27 patients (3-18 for phase I and 9 for phase II) will be
accrued for this study within 2-14 months.
Primary Purpose: Treatment
Immunological efficacy in terms of T-cell response as measured by enzyme-linked immunospot
Miguel-Angel Perales, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|