Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
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Purpose
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 | Intervention | 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 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
- Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor [ Designated as safety issue: No ]
- Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues [ Designated as safety issue: No ]
- Acute antitumor activity of treatment [ Designated as safety issue: No ]
- Long-term toxicity of treatment as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 108 |
| Study Start Date: | December 2006 |
| Study Completion Date: | August 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00436410 History of Changes |
| Other Study ID Numbers: | 070043, 07-C-0043, NCI-P6066, CYT-NCI-07-C-0043, CDR0000529849 |
| Study First Received: | February 15, 2007 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
recurrent adrenocortical carcinoma stage I adrenocortical carcinoma stage II adrenocortical carcinoma stage III adrenocortical carcinoma stage IV adrenocortical carcinoma stage IV colon cancer stage IV rectal cancer adult primary hepatocellular carcinoma stage IV pancreatic cancer male breast cancer stage IV breast cancer stage IV melanoma stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer recurrent breast cancer recurrent colon cancer stage I colon cancer stage II colon cancer stage III colon cancer recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer advanced adult primary liver cancer localized resectable adult primary liver cancer recurrent adult primary liver cancer recurrent pancreatic cancer |
Additional relevant MeSH terms:
|
Adrenocortical Carcinoma Breast Neoplasms Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Liver Neoplasms Melanoma Neoplasm Metastasis Ovarian Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Sarcoma Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013