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

NCT ID: NCT00436410

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-08-31

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 .

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

colloidal gold-bound tumor necrosis factor

Intervention Type: BIOLOGICAL

electron microscopy

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

NCI - Center for Cancer Research-Medical Oncology

Bethesda, Maryland, United States

NCI - Surgery Branch

Bethesda, Maryland, United States

Countries

United States

References

Kesharwani P, Ma R, Sang L, Fatima M, Sheikh A, Abourehab MAS, Gupta N, Chen ZS, Zhou Y. Gold nanoparticles and gold nanorods in the landscape of cancer therapy. Mol Cancer. 2023 Jun 21;22(1):98. doi: 10.1186/s12943-023-01798-8.

Reference Type: DERIVED

PMID: 37344887 (View on PubMed)

Other Identifiers

07-C-0043

Identifier Type: -

Identifier Source: secondary_id

NCI-P6066

Identifier Type: -

Identifier Source: secondary_id

CYT-NCI-07-C-0043

Identifier Type: -

Identifier Source: secondary_id

CDR0000529849

Identifier Type: -

Identifier Source: secondary_id

070043

Identifier Type: -

Identifier Source: org_study_id