Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Voriconazole

Criteria

DISEASE CHARACTERISTICS:

• Expected to develop neutropenia (absolute neutrophil count less than 500/mm^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions:

• Leukemia

• Lymphoma

• Aplastic anemia

• Preparation for a bone marrow or stem cell transplantation

• Requiring treatment for the prevention of systemic fungal infection

PATIENT CHARACTERISTICS:

Age

• 2 to 11

Performance status

• Not specified

Life expectancy

• More than 3 months

Hematopoietic

• See Disease Characteristics

Hepatic

• AST and ALT no greater than 5 times upper limit of normal (ULN)

• Bilirubin no greater than 5 times ULN

Renal

• Creatinine clearance at least 30 mL/min

Cardiovascular

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• No severe hypokalemia (potassium less than 3.2 mmol/L)

• No prior hypersensitivity to or severe intolerance of azole antifungal agents

• No other concurrent condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 24 hours since prior use of any of the following:

• Terfenadine

• Pimozide

• Quinidine

• Astemizole

• Cisapride

• Omeprazole

• More than 14 days since prior use of any of the following:

• Rifampin

• Rifabutin

• Carbamazepine

• Phenytoin

• Nevirapine

• Long-acting barbiturates

• No prior sirolimus

• No prior enrollment on this study

• No concurrent use of any of the following:

• Terfenadine

• Pimozide

• Quinidine

• Astemizole

• Cisapride

• Omeprazole

• No other concurrent investigational drugs except any of the following:

• Drugs used as treatment for cancer

• Antiretroviral agents

• Drugs used for the treatment of any AIDS-defining opportunistic infections

• No concurrent enrollment in investigational anticancer drug trials that exclude the use of other investigational agents