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Trial record 39 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00059878
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal infections. Combining voriconazole with interferon gamma may be more effective than voriconazole alone in treating fungal infections.

PURPOSE: Randomized phase II trial to compare the effectiveness of voriconazole with or without interferon gamma in treating patients who have aspergillosis or other fungal infections.

Condition or disease Intervention/treatment Phase
Infection Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interferon gamma Drug: voriconazole Phase 2

Detailed Description:


  • Determine the safety profile of voriconazole and interferon gamma in patients with invasive aspergillosis or other filamentous fungal infections.
  • Compare the efficacy and possible heterogeneity in efficacy of voriconazole with or without interferon gamma across different patient sub-populations, in terms of designing a larger phase II or pivotal phase III study.
  • Determine the time to partial or complete response and rate of response (at weeks 6 and 12 or at end of treatment and follow-up) in patients receiving interferon gamma.
  • Compare the proportion of patients with at least a two-fold reduction in the galactomannan antigenemia titer at 6 and 12 weeks or at end of treatment with these regimens.
  • Determine surrogate immunologic markers for response to interferon gamma, functional integrity and anti-fungal activity of phagocytic cells (neutrophils, monocytes, and macrophages), and nonphagocytic effector cells (natural killer and T cells) in these patients.

OUTLINE: This is a randomized, double-blind, multicenter, pilot study. Patients are stratified according to age (under 18 vs 18 and over) and absolute neutrophil count (less than 500/mm^3 vs at least 500/mm^3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive voriconazole (IV over 80-120 minutes for the first 3 doses and orally every 12 hours for subsequent doses) 3 times per week and interferon gamma subcutaneously (SC) 3 times per week.
  • Arm II: Patients receive voriconazole as in arm I and placebo SC 3 times per week.

In both arms, treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 88 patients (44 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized, Double-Blind, Multicenter Pilot Study Of The Safety And Efficacy Of Interferon Gamma- 1b (IFN-y 1b) Plus Voriconazole Versus Placebo Plus Voriconazole In The Treatment Of Invasive Aspergillosis And Other Filamentous Fungal Infections
Study Start Date : August 2003
Actual Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days
  • Presenting with 1 of the following:

    • Cancer
    • Aplastic anemia
    • Inherited immunodeficiencies
    • Autoimmune deficiency disorders
    • Acquired immunodeficiencies
    • Recipient of autologous peripheral blood stem cell or bone marrow transplantation
  • CNS aspergillosis or other filamentous fungal infection allowed
  • No invasive zygomycosis infection



  • 2 and over

Performance status

  • Not specified

Life expectancy

  • At least 7 days


  • Not specified


  • ALT no greater than 5 times upper limit of normal


  • Creatinine clearance at least 30 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No prior significant CNS disorder (e.g., multiple sclerosis or uncontrolled seizures)
  • No prior grade 3 or 4 toxicity or severe allergic reaction to interferon gamma
  • No prior intolerance or hypersensitivity to voriconazole or other azoles
  • No acute or chronic graft-versus-host disease
  • No conditions that would preclude study compliance


Biologic therapy

  • See Disease Characteristics
  • No prior allogeneic peripheral blood or bone marrow transplantation
  • No concurrent interferon alfa


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior solid organ transplantation


  • Prior voriconazole allowed
  • At least 24 hours since prior administration of any of the following:

    • Astemizole
    • Cisapride
    • Pimozide
    • Quinidine
    • Sirolimus
    • Terfenadine
    • Rifabutin
    • Ergot alkaloids
    • Sildenafil citrate
    • Amiodarone
    • Flecainide
    • Systemic lidocaine
  • More than 14 days since prior long-acting barbiturates, carbamazepine, or rifampin
  • No other concurrent systemic antifungal drugs
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00059878

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United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Florida
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-100277
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Thomas J. Walsh, MD National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00059878     History of Changes
Other Study ID Numbers: CDR0000298887
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: July 2004
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inhibitors
Communicable Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs