Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer

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: NCT00436410
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : May 2, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

February 15, 2007
February 19, 2007
May 2, 2012
December 2006
Not Provided
  • Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
  • Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
Same as current
Complete list of historical versions of study NCT00436410 on Archive Site
  • Acute antitumor activity of treatment
  • Long-term toxicity of treatment as assessed by CTCAE v3.0
Same as current
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Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection

RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.

PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery for primary cancer or metastatic cancer .



  • Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.


  • Determine, by histological examination of resected tumor tissue, the acute antitumor effects of this treatment in these patients.
  • Determine the long-term toxicities of this treatment in these patients.
  • Determine the response to this treatment in these patients.

OUTLINE: This is a cohort study. Patients are stratified according to disease type (colorectal cancer vs hepatocellular cancer vs pancreatic exocrine cancer vs pancreatic endocrine cancer vs breast cancer vs melanoma vs primary adrenal tumors vs renal cell carcinoma).

Patients receive colloidal gold-bound tumor necrosis factor IV over 15-30 seconds 12-78 hours prior to surgery. Patients then undergo standard-care surgery.

Tumor and normal tissues are removed during surgery for analysis of antitumor effects and tissue distribution of colloidal gold-bound tumor necrosis factor by electron microscopy.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.

Early Phase 1
Primary Purpose: Treatment
  • Adrenocortical Carcinoma
  • Breast Cancer
  • Colorectal Cancer
  • Gastrointestinal Cancer
  • Kidney Cancer
  • Liver Cancer
  • Melanoma (Skin)
  • Ovarian Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Biological: colloidal gold-bound tumor necrosis factor
  • Other: electron microscopy
  • Other: pharmacological study
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2009
Not Provided


  • Histologically confirmed primary or metastatic malignancy, including any of the following:

    • Colorectal cancer
    • Hepatocellular cancer
    • Pancreatic exocrine cancer
    • Pancreatic endocrine cancer
    • Breast cancer
    • Melanoma
    • Sarcoma
    • Primary adrenal tumors
    • Renal cell carcinoma
    • Ovarian cancer
    • Adenocarcinoma of gastrointestinal origin
    • Peritoneal mesothelioma
  • Clinical indication for surgical resection
  • No known brain metastases

    • Previously treated brain metastases with no evidence of recurrence allowed
  • Hormone receptor status not specified


  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy ≥ 5 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 ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Hemoglobin ≥ 9.0 g/dL
  • Ejection fraction ≥ 45% by echocardiogram, thallium stress test, or MUGA (for patients with prior cardiovascular disease)
  • FEV_1 OR DLCO > 30% of predicted (for patients with prior pulmonary disease)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active bacterial infection

    • Localized chronic infection (e.g., mild acne, tinea pedis) allowed
  • No known bleeding disorder
  • No other serious illness including, but not limited to, any of the following:

    • Unstable angina
    • Severe oxygen-dependent chronic obstructive pulmonary disease
    • End-stage liver disease
  • No HIV positivity


  • Recovered from prior therapy, including cytotoxic drugs, radiotherapy, surgery, or other anticancer modalities
  • More than 3 weeks since prior biologic therapy or cytotoxic agents (6 weeks for nitrosoureas) and recovered
  • No concurrent treatment in a protocol for which patient is being evaluated for response
  • No other concurrent anticancer treatment
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)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
National Institutes of Health Clinical Center (CC)
May 2012

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