TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00356980

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-04-30

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

colloidal gold-bound tumor necrosis factor

Intervention Type: BIOLOGICAL

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Steven K. Libutti, MD

Role: PRINCIPAL_INVESTIGATOR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

NCI - Surgery Branch

Bethesda, Maryland, United States

Countries

United States

References

Libutti 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.

Reference Type: RESULT

PMID: 20876255 (View on PubMed)

Kesharwani 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.

Reference Type: DERIVED

PMID: 37344887 (View on PubMed)

Other Identifiers

06-C-0167

Identifier Type: -

Identifier Source: secondary_id

NCI-P6062

Identifier Type: -

Identifier Source: secondary_id

CYT-6091-06-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000486917

Identifier Type: -

Identifier Source: secondary_id

060167

Identifier Type: -

Identifier Source: org_study_id

NCT00328406

Identifier Type: -

Identifier Source: nct_alias