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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00356980
First received: July 26, 2006
Last updated: March 14, 2012
Last verified: March 2012
  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 1

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:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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
Study Completion Date: April 2009
Primary Completion Date: February 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
Investigators
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00356980     History of Changes
Obsolete Identifiers: NCT00328406
Other Study ID Numbers: 060167, 06-C-0167, NCI-P6062, CYT-6091-06-01, CDR0000486917
Study First Received: July 26, 2006
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 15, 2014