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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356980
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : March 15, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

July 26, 2006
July 27, 2006
March 15, 2012
May 2006
February 2009   (Final data collection date for primary outcome measure)
  • Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
  • Toxicity
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Complete list of historical versions of study NCT00356980 on Archive Site
  • 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
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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

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.



  • 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.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: colloidal gold-bound tumor necrosis factor
  • Other: pharmacological study
Not Provided
Libutti SK, Paciotti GF, Byrnes AA, Alexander HR Jr, Gannon WE, Walker M, Seidel GD, Yuldasheva N, Tamarkin L. Phase I and pharmacokinetic studies of CYT-6091, a novel PEGylated colloidal gold-rhTNF nanomedicine. Clin Cancer Res. 2010 Dec 15;16(24):6139-49. doi: 10.1158/1078-0432.CCR-10-0978. Epub 2010 Sep 27.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
April 2009
February 2009   (Final data collection date for primary outcome measure)


  • Histologically confirmed solid tumor
  • Advanced and/or metastatic disease
  • Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists
  • Measurable or evaluable metastatic disease
  • No lymphoma or other hematologic malignancy
  • No known brain metastases

    • Previously treated brain metastases with no evidence of recurrence allowed


  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.5 mg/dL
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
  • Prothrombin time ≤ 1.5 times ULN
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • LVEF ≥ 45% by echocardiogram or thallium stress test for patients > 50 years of age or history of cardiovascular disease
  • FEV_1 and DLCO > 30% of predicted for patients with a history of pulmonary disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis)

    • Localized chronic infections, such as mild acne or tinea pedis allowed
  • No acute or chronic viral hepatitis
  • No known bleeding disorder
  • No other concurrent life-threatening illness, including any of the following:

    • Unstable angina
    • Severe oxygen-dependent chronic obstructive pulmonary disease
    • End-stage liver disease
  • No known active renal disease or renal insufficiency as evidenced by serum creatinine > 2.0 mg/dL
  • No HIV positivity


  • Recovered from prior therapy
  • More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas)
  • No known requirment for palliative treatment
  • No concurrent surgery
  • No other concurrent anticancer therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
National Institutes of Health Clinical Center (CC)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP