An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection
- Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor
necrosis factor in patients with primary or metastatic cancer undergoing surgery.
- Determine, by histological examination of resected tumor tissue, the acute antitumor
effects of this treatment in these patients.
- Determine the long-term toxicities of this treatment in these patients.
- Determine the response to this treatment in these patients.
OUTLINE: This is a cohort study. Patients are stratified according to disease type
(colorectal cancer vs hepatocellular cancer vs pancreatic exocrine cancer vs pancreatic
endocrine cancer vs breast cancer vs melanoma vs primary adrenal tumors vs renal cell
Patients receive colloidal gold-bound tumor necrosis factor IV over 15-30 seconds 12-78
hours prior to surgery. Patients then undergo standard-care surgery.
Tumor and normal tissues are removed during surgery for analysis of antitumor effects and
tissue distribution of colloidal gold-bound tumor necrosis factor by electron microscopy.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.
Primary Purpose: Treatment
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|NCI - Surgery Branch||Bethesda, Maryland 20892-1201|
|NCI - Center for Cancer Research-Medical Oncology||Bethesda, Maryland 20892-1182|