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

National Cancer Institute (NCI) logo

National Cancer Institute (NCI)

Status and phase

Completed
Phase 2

Conditions

Infection
Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Biological: recombinant interferon gamma
Drug: voriconazole

Study type

Interventional

Funder types

NIH

Identifiers

NCT00059878
NCI-03-C-0111
CDR0000298887

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

  • 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.

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 2 and over

Performance status

  • Not specified

Life expectancy

  • At least 7 days

Hematopoietic

  • Not specified

Hepatic

  • ALT no greater than 5 times upper limit of normal

Renal

  • Creatinine clearance at least 30 mL/min

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior solid organ transplantation

Other

  • 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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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