Clinical trial NCT00436410: Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adrenocortical Carcinoma
Breast Cancer
Colorectal Cancer
Gastrointestinal Cancer
Kidney Cancer
Liver Cancer
Melanoma (Skin)
Ovarian Cancer
Pancreatic Cancer
Sarcoma
Keywords: 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 adrenocortical carcinoma
stage I adrenocortical carcinoma
stage II adrenocortical carcinoma
stage III adrenocortical carcinoma
stage IV adrenocortical carcinoma
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
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent melanoma
stage I melanoma
stage II melanoma
stage III melanoma
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
recurrent ovarian epithelial cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
gastrointestinal cancer
adult fibrosarcoma
recurrent adult soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
measure: Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
Secondary outcomes:
measure: Acute antitumor activity of treatment
measure: Long-term toxicity of treatment as assessed by CTCAE v3.0
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: NCI - Center for Cancer Research-Medical Oncology
state: Maryland
city: Bethesda
country: United States
facility: NCI - Surgery Branch
state: Maryland
Study officials:
affiliation: NCI - Surgery Branch
name: Steven A. Rosenberg, MD, PhD
role: STUDY_CHAIR
References: