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| ID | Type | Description | Link |
|---|---|---|---|
| 07-C-0043 | |||
| NCI-P6066 | |||
| CYT-NCI-07-C-0043 | |||
| CDR0000529849 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 .
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colloidal gold-bound tumor necrosis factor | Biological | |||
| electron microscopy | Other | |||
| pharmacological study | Other | |||
| conventional surgery | Procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute antitumor activity of treatment | ||
| Long-term toxicity of treatment as assessed by CTCAE v3.0 |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary or metastatic malignancy, including any of the following:
Clinical indication for surgical resection
No known brain metastases
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
No known bleeding disorder
No other serious illness including, but not limited to, any of the following:
No HIV positivity
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCI - Center for Cancer Research-Medical Oncology | Bethesda | Maryland | 20892-1182 | United States | ||
| NCI - Surgery Branch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37344887 | Derived | 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. |
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| Bethesda |
| Maryland |
| 20892-1201 |
| United States |
| ID | Term |
|---|---|
| D018268 | Adrenocortical Carcinoma |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D007680 | Kidney Neoplasms |
| D008113 | Liver Neoplasms |
| D008545 | Melanoma |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012509 | Sarcoma |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D018567 | Breast Neoplasms, Male |
| D002292 | Carcinoma, Renal Cell |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005354 | Fibrosarcoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008107 | Liver Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
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| ID | Term |
|---|---|
| C000604550 | CYT-6091 |
| D008854 | Microscopy, Electron |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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