NCT00356980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

July 26, 2006

Last Update Submit

March 14, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

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

  • Toxicity

Secondary Outcomes (9)

  • Pharmacokinetic profile of CYT-6091

  • Measurements of CYT-6091 in tumor biopsies

  • Tumor biopsy histology and gene expression after treatment

  • Immunogenicity of CYT-6091

  • Electron microscopy of biopsy to determine presence of colloidal gold

  • +4 more secondary outcomes

Interventions

colloidal gold-bound tumor necrosis factorBIOLOGICAL
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

Related Publications (2)

  • 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.

    PMID: 20876255RESULT

  • 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.

    PMID: 37344887DERIVED

MeSH Terms

Interventions

CYT-6091

Study Officials

  • Steven K. Libutti, MD

    NCI - Surgery Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

May 1, 2006

Primary Completion

February 1, 2009

Study Completion

April 1, 2009

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(2)