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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00356980
Enrollment
60
Registered
2006-07-27
Start date
2006-05-31
Completion date
2009-04-30
Last updated
2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors. * Determine the toxicities of CYT-6091 in these patients. Secondary * Determine the pharmacokinetics of CYT-6091 in these patients. * Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091. * Determine if antitumor effects of CYT-6091 occur in these patients. OUTLINE: This is an open-label, sequential cohort, dose-escalation study. Patients receive TNF-bound colloidal gold (CYT-6091) IV on days 1 and 15 (course 1). Approximately 4-6 weeks later, patients are re-staged and responding patients may receive another course of therapy. Patients may receive up to 3 re-treatment courses. Cohorts of 3-6 patients receive escalating doses of CYT-6091 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. Blood samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic and pharmacodynamic analyses. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for the next year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Interventions

OTHERpharmacological study

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Toxicity

Secondary

MeasureTime frame
Measurements of CYT-6091 in tumor biopsies
Tumor biopsy histology and gene expression after treatment
Immunogenicity of CYT-6091
Duration of stable disease
Response of target and nontarget lesions
Overall response
Duration of response
Electron microscopy of biopsy to determine presence of colloidal gold
Pharmacokinetic profile of CYT-6091

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026