Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059878
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-05-06
Brief Title:
Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 500mm3 vs at least 500mm3 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
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 500mm3 vs at least 500mm3 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0111 | None | None | None |