Anidulafungin in Treating Immunocompromised Children With Neutropenia

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.

PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Anidulafungin; Echinocandins

Criteria

DISEASE CHARACTERISTICS:

• Neutropenia due to cytotoxic chemotherapy or aplastic anemia

• Duration expected to be 10 days

• Absolute neutrophil count less than 500/mm^3 OR less than 1,000/mm^3 and expected to fall below 500/mm^3 within 72 hours

• No deeply invasive fungal infection confirmed prior to study entry

PATIENT CHARACTERISTICS:

Age

• 2 to 17

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

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

• Bilirubin no greater than 2.5 times ULN

Renal

• Creatinine clearance at least 30 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for at least 30 days after study participation

• No prior anaphylaxis attributed to the echinocandin class of antifungals

• No other concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since prior investigational drugs

• No prior participation in this clinical trial

• No prior anidulafungin

• No other concurrent investigational drugs

• No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents)

• Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed

• Concurrent broad-spectrum antibiotics allowed