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

Primary Purpose

Infection, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon gamma
voriconazole
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring infection, unspecified adult solid tumor, protocol specific

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Shands Cancer Center at the University of Florida Health Science Center
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059878
Brief Title
Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections
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 Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
infection, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon gamma
Intervention Type
Drug
Intervention Name(s)
voriconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Walsh, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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