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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00436410

Collaborator

National Cancer Institute (NCI) (NIH)

108

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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 .

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

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 Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2006

Actual Study Completion Date :

Aug 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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