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

May 1, 2012 updated by: National Institutes of Health Clinical Center (CC)

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

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

Secondary

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1201
        • NCI - Surgery Branch
      • Bethesda, Maryland, United States, 20892-1182
        • NCI - Center for Cancer Research-Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
Acute antitumor activity of treatment
Long-term toxicity of treatment as assessed by CTCAE v3.0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (ESTIMATE)

February 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070043
  • 07-C-0043
  • NCI-P6066
  • CYT-NCI-07-C-0043
  • CDR0000529849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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