TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: colloidal gold-bound tumor necrosis factor
Other: pharmacological study
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies|
- Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Pharmacokinetic profile of CYT-6091 [ Designated as safety issue: No ]
- Measurements of CYT-6091 in tumor biopsies [ Designated as safety issue: No ]
- Tumor biopsy histology and gene expression after treatment [ Designated as safety issue: No ]
- Immunogenicity of CYT-6091 [ Designated as safety issue: No ]
- Electron microscopy of biopsy to determine presence of colloidal gold [ Designated as safety issue: No ]
- Response of target and nontarget lesions [ Designated as safety issue: No ]
- Overall response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Duration of stable disease [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, Maryland|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892-1201|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Steven K. Libutti, MD||NCI - Surgery Branch|