Status:
COMPLETED
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adrenocortical Carcinoma
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
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. Secon...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00436410
Start Date
December 1 2006
End Date
August 1 2009
Last Update
May 2 2012
Active Locations (2)
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1
NCI - Center for Cancer Research-Medical Oncology
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201