TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00356980
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) Toxicity
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
NCI - Surgery Branch
🇺🇸Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
🇺🇸Bethesda, Maryland, United States