NCT00436410

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2006

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

First QC Date

February 15, 2007

Last Update Submit

May 1, 2012

Conditions

Adrenocortical CarcinomaBreast CancerColorectal CancerGastrointestinal CancerKidney CancerLiver CancerMelanoma (Skin)Ovarian CancerPancreatic CancerSarcoma

Keywords

stage IV colon cancerstage IV rectal canceradult primary hepatocellular carcinomastage IV pancreatic cancermale breast cancerstage IV breast cancerstage IV melanomastage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerrecurrent breast cancerrecurrent adrenocortical carcinomastage I adrenocortical carcinomastage II adrenocortical carcinomastage III adrenocortical carcinomastage IV adrenocortical carcinomarecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal canceradvanced adult primary liver cancerlocalized resectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent pancreatic cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent melanomastage I melanomastage II melanomastage III melanomastage I renal cell cancerstage II renal cell cancerstage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerrecurrent ovarian epithelial cancerstage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancergastrointestinal canceradult fibrosarcomarecurrent adult soft tissue sarcomastage I adult soft tissue sarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Acute antitumor activity of treatment

  • Long-term toxicity of treatment as assessed by CTCAE v3.0

Interventions

colloidal gold-bound tumor necrosis factorBIOLOGICAL
electron microscopyOTHER
pharmacological studyOTHER
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

NCI - Center for Cancer Research-Medical Oncology

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

Related Publications (1)

  • 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.

    PMID: 37344887DERIVED

MeSH Terms

Conditions

Adrenocortical CarcinomaBreast NeoplasmsColorectal NeoplasmsGastrointestinal NeoplasmsKidney NeoplasmsLiver NeoplasmsMelanomaOvarian NeoplasmsPancreatic NeoplasmsSarcomaColonic NeoplasmsRectal NeoplasmsCarcinoma, HepatocellularBreast Neoplasms, MaleCarcinoma, Renal CellCarcinoma, Ovarian EpithelialFibrosarcoma

Interventions

CYT-6091Microscopy, Electron

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLiver DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesGonadal DisordersPancreatic DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Fibrous TissueNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Steven A. Rosenberg, MD, PhD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 19, 2007

Study Start

December 1, 2006

Study Completion

August 1, 2009

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations

US(2)