NCT00356980

TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors

A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	colloidal gold-bound tumor necrosis factor
OTHER	pharmacological study

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-02-01
• Completion: 2009-04-01
• First posted: 2006-07-27
• Last updated: 2012-03-15

Locations

2 sites across 1 country: United States