Clinical trial · Interventional

Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer

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

NCT00436410CI-TRIAL-00006830completedEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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 .

Conditions

Conditions (10)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adrenocortical Carcinoma	Adrenal Cortical Carcinoma	ALIAS	0.90
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Gastrointestinal Cancer	Malignant Digestive System Neoplasm	ALIAS	0.90
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Melanoma (Skin)	Melanoma	ONTOLOGY_EXACT	0.85
Ovarian Cancer	Malignant Ovarian Neoplasm

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
colloidal gold-bound tumor necrosis factor	Biological	—	UNRESOLVED
conventional surgery	Procedure	—	UNRESOLVED
electron microscopy	Other	—	UNRESOLVED
pharmacological study	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

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 (2)

measure
Acute antitumor activity of treatment
measure
Long-term toxicity of treatment as assessed by CTCAE v3.0

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDKesharwani 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 37344887

Registry

Dates and enrollment