Phase II Trial for the Evaluation of the Efficacy of Vaccination With Synthetic Melanoma Peptides Either Pulsed on Dendritic Cells, or Administered With GM-CSF-in-Adjuvant, Plus Administration of Sustemic IL-2, in Patients With Advanced Melanoma.
OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides
pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides
plus sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma
(pulsed autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens
result in increased tumor specific immune responses as measured in vitro and in vivo. III.
Determine whether these regimens stimulate T-cell responses in these patients.
OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I
closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients
receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients
receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally.
Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and
interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different
sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are
evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months.
PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.
Interventional
Primary Purpose: Treatment
Craig L. Slingluff, MD
Study Chair
University of Virginia
United States: Federal Government
CDR0000066084
NCT00003222
April 1998
Name | Location |
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Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |