Know Cancer

or
forgot password

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 SciencesLittle Rock, Arkansas  72205
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182