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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Pilot Study of Voriconazole With or Without Interferon gamma in Patients With Invasive Aspergillosis or Other Filamentous Fungal Infections

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Completed	2 and over	NCI	NCI-03-C-0111 NCT00059878

Trial Description

Purpose:

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.

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.

Eligibility:

• At least 2 years old
• No previous allogeneic stem cell transplantation or allogeneic bone marrow transplantation
• No previous organ transplantation
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive an 80-minute to 2-hour infusion of voriconazole three times in week 1. Beginning in week 2, they will receive voriconazole by mouth twice a day three times a week. Patients will also receive an injection of interferon gamma three times a week.

Patients in group two will receive voriconazole as in group one and an injection of a placebo three times a week.

Treatment in both groups may continue for 12 weeks. Patients will be evaluated at 4 weeks.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Thomas Walsh, MD, Protocol chair		Ph: 301-402-0023

Registry Information
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
Trial Start Date		2003-08-08
Registered in ClinicalTrials.gov		NCT00059878
Date Submitted to PDQ		2003-03-12
Information Last Verified		2004-07-09

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