NCT00059878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

June 19, 2013

Status Verified

July 1, 2004

First QC Date

May 6, 2003

Last Update Submit

June 17, 2013

Conditions

InfectionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

infectionunspecified adult solid tumor, protocol specific

Interventions

recombinant interferon gammaBIOLOGICAL
voriconazoleDRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Shands Cancer Center at the University of Florida Health Science Center

Gainesville, Florida, 32610-100277, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Interferon-gammaVoriconazole

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological FactorsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas J. Walsh, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

August 1, 2003

Study Completion

January 1, 2005

Last Updated

June 19, 2013

Record last verified: 2004-07

Locations

US(3)