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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00436410
First received: February 15, 2007
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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 Intervention 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
Phase 0

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor [ Designated as safety issue: No ]
  • Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute antitumor activity of treatment [ Designated as safety issue: No ]
  • Long-term toxicity of treatment as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: December 2006
Study Completion Date: August 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436410

Locations
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
Investigators
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00436410     History of Changes
Other Study ID Numbers: 070043, 07-C-0043, NCI-P6066, CYT-NCI-07-C-0043, CDR0000529849
Study First Received: February 15, 2007
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Melanoma
Neoplasm Metastasis
Ovarian Neoplasms
Pancreatic Neoplasms
Adrenocortical Carcinoma
Gastrointestinal Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 24, 2014