A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Steven K. Libutti, MD
NCI - Surgery Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Surgery Branch||Bethesda, Maryland 20892-1201|