Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436410
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2007-02-15
Brief Title:
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000529849 | None | None | None |
| 07-C-0043 | None | None | None |
| NCI-P6066 | None | None | None |
| CYT-NCI-07-C-0043 | None | None | None |