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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436410
• Other study ID #: 070043
• Secondary ID: 07-C-0043NCI-P60
• Status: Completed
• Phase: Phase 0
• First received: February 15, 2007
• Last updated: May 1, 2012
• Start date: December 2006
• Est. completion date: August 2009

Study information

• Verified date: May 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Breast Cancer
• Colorectal Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Kidney Cancer
• Liver Cancer
• Liver Neoplasms
• Melanoma (Skin)
• Neoplasm Metastasis
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Sarcoma

Intervention

Biological:
• colloidal gold-bound tumor necrosis factor

Other:
• electron microscopy

• pharmacological study

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	NCI - Center for Cancer Research-Medical Oncology	Bethesda	Maryland
United States	NCI - Surgery Branch	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor			No
Primary	Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues			No
Secondary	Acute antitumor activity of treatment			No
Secondary	Long-term toxicity of treatment as assessed by CTCAE v3.0			Yes