Gene Therapy in Treating Patients With Metastatic Melanoma
RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have metastatic melanoma.
Biological: staphylococcal enterotoxin B
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma|
|Study Start Date:||February 2000|
|Study Completion Date:||September 2001|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005943
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80262|
|Study Chair:||Patrick Walsh, MD||University of Colorado, Denver|