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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


Phase 2
2 Years
N/A
Not Enrolling
Both
Infection, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Thomas J. Walsh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000298887

NCT ID:

NCT00059878

Start Date:

August 2003

Completion Date:

January 2005

Related Keywords:

  • Infection
  • Unspecified Adult Solid Tumor, Protocol Specific
  • infection
  • unspecified adult solid tumor, protocol specific
  • Aspergillosis
  • Mycoses

Name

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Shands Cancer Center at the University of Florida Health Science Center Gainesville, Florida  32610-0296
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182