CompletedEarly Phase 1

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

United States108 participantsStarted 2006-12

Plain-language 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 .

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 followi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00436410

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

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