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TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
This study has been completed.

First Received on July 26, 2006.   Last Updated on April 13, 2011   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00356980
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
 Biological: colloidal gold-bound tumor necrosis factor
Other: pharmacological study
 Phase I

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Tumor Necrosis Factors
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of CYT-6091 [ Designated as safety issue: No ]
  • Measurements of CYT-6091 in tumor biopsies [ Designated as safety issue: No ]
  • Tumor biopsy histology and gene expression after treatment [ Designated as safety issue: No ]
  • Immunogenicity of CYT-6091 [ Designated as safety issue: No ]
  • Electron microscopy of biopsy to determine presence of colloidal gold [ Designated as safety issue: No ]
  • Response of target and nontarget lesions [ Designated as safety issue: No ]
  • Overall response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Duration of stable disease [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356980

Locations
United States, Maryland
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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. Epub 2010 Sep 27.

ClinicalTrials.gov Identifier: NCT00356980     History of Changes
Obsolete Identifiers: NCT00328406
Other Study ID Numbers: CDR0000486917, NCI-06-C-0167, NCI-P6062, CYT-6091-06-01
Study First Received: July 26, 2006
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012



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