Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer
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
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