Clinical trial · Interventional
TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
NCT00356980CI-TRIAL-00006505completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal gold in treating patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colloidal gold-bound tumor necrosis factor | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
- measure
- Toxicity
Secondary outcomes (9)
- measure
- Pharmacokinetic profile of CYT-6091
- measure
- Measurements of CYT-6091 in tumor biopsies
- measure
- Tumor biopsy histology and gene expression after treatment
- measure
- Immunogenicity of CYT-6091
- measure
- Electron microscopy of biopsy to determine presence of colloidal gold
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Advanced and/or metastatic disease * Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists * Measurable or evaluable metastatic disease * No lymphoma or other hematologic malignancy * No known brain metastases * Previously treated brain metastases with no evidence of recurrence allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 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 ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) * Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present) * Prothrombin time ≤ 1.5 times ULN * Hemoglobin ≥ 10.0 g/dL (transfusion allowed) * LVEF ≥ 45% by echocardiogram or thallium stress test for patients \> 50 years of age or history of cardiovascular disease * FEV\_1 and DLCO \> 30% of predicted for patients with a history of pulmonary disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis) * Localized chronic infections, such as mild acne or tinea pedis allowed * No acute or chronic viral hepatitis * No known bleeding disorder * No other concurrent life-threatening illness, including any of the following: * Unstable angina * Severe oxygen-dependent chronic obstructive pulmonary disease * End-stage liver disease * No known active renal disease or renal insufficiency as evidenced by serum creatinine \> 2.0 mg/dL * No HIV positivity PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas) * No known requirment for palliative treatment * No concurrent surgery * No other concurrent anticancer therapy
References
Publications (2)
- RESULTLibutti SK, Paciotti GF, Byrnes AA, Alexander HR Jr, Gannon WE, Walker M, Seidel GD, Yuldasheva N, Tamarkin L. Phase I and pharmacokinetic studies of CYT-6091, a novel PEGylated colloidal gold-rhTNF nanomedicine. Clin Cancer Res. 2010 Dec 15;16(24):6139-49. doi: 10.1158/1078-0432.CCR-10-0978. Epub 2010 Sep 27. PMID 20876255
- 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