TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00356980|
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : March 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: colloidal gold-bound tumor necrosis factor Other: pharmacological study||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||April 2009|
- Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356980
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892-1201|
|Principal Investigator:||Steven K. Libutti, MD||NCI - Surgery Branch|