Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00059878 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: recombinant interferon gamma Drug: voriconazole |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
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 Start Date: | August 2003 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Presenting with 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 24 hours since prior administration of any of the following:
United States, Arkansas | |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, Florida | |
Shands Cancer Center at the University of Florida Health Science Center | |
Gainesville, Florida, United States, 32610-100277 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Thomas J. Walsh, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000298887, NCI-03-C-0111 |
Study First Received: | May 6, 2003 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00059878 |
Health Authority: | United States: Federal Government |
infection unspecified adult solid tumor, protocol specific |
Mycoses Interferon Type II Clotrimazole Miconazole Voriconazole |
Interferons Tioconazole Aspergillosis Interferon-gamma, Recombinant |
Anti-Infective Agents Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Infection Antiviral Agents Pharmacologic Actions |