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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00356980

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

A Phase 1 study testing colloidal gold-bound tumor necrosis factor and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
colloidal gold-bound tumor necrosis factor and pharmacological study
How many people
60 participants
Where
2 sitesUnited States
Study dates
May 2006to Apr 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

  • NCI - Surgery Branch

    Bethesda, Maryland, 20892-1201

Other trials in United States

About this study

Official title: A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies

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.

Read the 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.

Being tested
colloidal gold-bound tumor necrosis factor, pharmacological study
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)

  2. Toxicity

Secondary outcomes (9)

  1. Pharmacokinetic profile of CYT-6091

  2. Measurements of CYT-6091 in tumor biopsies

  3. Tumor biopsy histology and gene expression after treatment

  4. Immunogenicity of CYT-6091

  5. Electron microscopy of biopsy to determine presence of colloidal gold

  6. Response of target and nontarget lesions

  7. Overall response

  8. Duration of response

  9. Duration of stable disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionFeb 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00356980
Sponsor's protocol ID
060167
Other IDs
06-C-0167, NCI-P6062, CYT-6091-06-01, CDR0000486917
Status last verified
Mar 2012
First submitted
26 Jul 2006
Last updated
15 Mar 2012
Results posted
No

Publications

  • 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.

    PubMed 20876255

  • 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.

    PubMed 37344887

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing colloidal gold-bound tumor necrosis factor and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.

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