Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00436410|
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : May 2, 2012
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 .
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma Breast Cancer Colorectal Cancer Gastrointestinal Cancer Kidney Cancer Liver Cancer Melanoma (Skin) Ovarian Cancer Pancreatic Cancer Sarcoma||Biological: colloidal gold-bound tumor necrosis factor Other: electron microscopy Other: pharmacological study Procedure: conventional surgery||Early Phase 1|
- Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Official Title:||An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||August 2009|
- 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
- Acute antitumor activity of treatment
- Long-term toxicity of treatment as assessed by CTCAE v3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436410
|United States, Maryland|
|NCI - Center for Cancer Research-Medical Oncology|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Surgery Branch|
|Bethesda, Maryland, United States, 20892-1201|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|