search
Back to results

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

Primary Purpose

Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
colloidal gold-bound tumor necrosis factor
electron microscopy
pharmacological study
conventional surgery
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenocortical Carcinoma focused on measuring 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, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, recurrent ovarian epithelial cancer, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, gastrointestinal cancer, adult fibrosarcoma, recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NCI - Center for Cancer Research-Medical Oncology
  • NCI - Surgery Branch

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 15, 2007
Last Updated
May 1, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00436410
Brief Title
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer, Kidney Cancer, Liver Cancer, Melanoma (Skin), Ovarian Cancer, Pancreatic Cancer, Sarcoma
Keywords
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, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent melanoma, stage I melanoma, stage II melanoma, stage III melanoma, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, recurrent ovarian epithelial cancer, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, gastrointestinal cancer, adult fibrosarcoma, recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
colloidal gold-bound tumor necrosis factor
Intervention Type
Other
Intervention Name(s)
electron microscopy
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
Title
Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
Secondary Outcome Measure Information:
Title
Acute antitumor activity of treatment
Title
Long-term toxicity of treatment as assessed by CTCAE v3.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Rosenberg, MD, PhD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
NCI - Center for Cancer Research-Medical Oncology
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
NCI - Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs