RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal gold in treating patients with advanced solid tumors.
OBJECTIVES: Primary * Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors. * Determine the toxicities of CYT-6091 in these patients. Secondary * Determine the pharmacokinetics of CYT-6091 in these patients. * Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091. * Determine if antitumor effects of CYT-6091 occur in these patients. OUTLINE: This is an open-label, sequential cohort, dose-escalation study. Patients receive TNF-bound colloidal gold (CYT-6091) IV on days 1 and 15 (course 1). Approximately 4-6 weeks later, patients are re-staged and responding patients may receive another course of therapy. Patients may receive up to 3 re-treatment courses. Cohorts of 3-6 patients receive escalating doses of CYT-6091 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. Blood samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic and pharmacodynamic analyses. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for the next year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
NCI - Surgery Branch
Bethesda, Maryland, United States
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Toxicity
Pharmacokinetic profile of CYT-6091
Measurements of CYT-6091 in tumor biopsies
Tumor biopsy histology and gene expression after treatment
Immunogenicity of CYT-6091
Electron microscopy of biopsy to determine presence of colloidal gold
Response of target and nontarget lesions
Overall response
Duration of response
Duration of stable disease
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