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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)

Brief Summary:

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 .

Condition or disease Intervention/treatment Phase
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 Early Phase 1

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Study Completion Date : August 2009

Primary Outcome Measures :
  1. Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
  2. Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues

Secondary Outcome Measures :
  1. Acute antitumor activity of treatment
  2. Long-term toxicity of treatment as assessed by CTCAE v3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00436410

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United States, Maryland
NCI - Center for Cancer Research-Medical Oncology
Bethesda, Maryland, United States, 20892-1182
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch

Layout table for additonal information Identifier: NCT00436410     History of Changes
Other Study ID Numbers: 070043
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV colon cancer
stage IV rectal cancer
adult primary hepatocellular carcinoma
stage IV pancreatic cancer
male breast cancer
stage IV breast cancer
stage IV melanoma
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent breast cancer
recurrent adrenocortical carcinoma
stage I adrenocortical carcinoma
stage II adrenocortical carcinoma
stage III adrenocortical carcinoma
stage IV adrenocortical carcinoma
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
advanced adult primary liver cancer
localized resectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent pancreatic cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Kidney Neoplasms
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases