A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma
OBJECTIVES: I. Determine the maximum tolerated dose of liposome complexed staphylococcal
enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma. II.
Determine local gene expression in tumor tissues in this patient population treated with
this regimen. III. Determine if plasmid DNA can be detected in circulation following
intratumoral injection of this regimen in this patient population. IV. Evaluate the
antitumor immune responses induced by this treatment regimen in these patients. V.
Characterize the clinical response to this treatment regimen in terms of tumor size and
histology in these patients. VI. Determine the clinical response to this treatment regimen
in terms of complete remission, partial remission, stable disease, and disease progression
in these patients.
OUTLINE: This is a dose escalation study. Patients receive intratumoral liposome complexed
staphylococcal enterotoxin B (SEB) and interleukin-2 (IL-2) plasmid DNA injections into 1-3
tumor nodules once every 2 weeks. Treatment continues for 6 courses in the absence of
disease progression or unacceptable toxicity. Patients with complete regression during
therapy may receive additional therapy to previously untreated tumor nodules. Patients with
partial response at 4 weeks following the last injection may continue therapy once every 4
weeks until no residual tumor remains. Cohorts of 3 patients each receive escalating doses
of SEB and IL-2 plasmid DNA until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Primary Purpose: Treatment
Patrick Walsh, MD
University of Colorado, Denver
United States: Federal Government
|University of Colorado||Denver, Colorado 80217|