Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal Infections

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Interferon-gamma; Interferons; Voriconazole

Criteria

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