Clinical trial · Interventional
Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infection | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon gamma | Biological | — | UNRESOLVED |
| voriconazole | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available