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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer, Kidney Cancer, Liver Cancer, Melanoma (Skin), Ovarian Cancer, Pancreatic Cancer, Sarcoma

Intervention / Treatment
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* Biological: colloidal gold-bound tumor necrosis factor
* Other: electron microscopy
* Other: pharmacological study
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: colloidal gold-bound tumor necrosis factor|nan|
|Other: electron microscopy|nan|
|Other: pharmacological study|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I renal cell cancer, 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 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