Caspofungin Acetate in Treating Children With Fever and Neutropenia

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.

PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Immunocompromised with one or more of the following conditions:

• Leukemia, lymphoma, or other cancer

• Underwent bone marrow or peripheral blood stem cell transplantation

• Aplastic anemia

• Planned chemotherapy likely to incur more than 10 days of neutropenia

• Absolute neutrophil count no greater than 500/mm^3 AND at least 1 recorded fever over 38.0 ° C within 24 hours of study

• No proven invasive fungal infection at time of study entry

• Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or candidal vaginitis) treatable with topical antifungals allowed

PATIENT CHARACTERISTICS:

Age:

• 2 to 17

Performance status:

• Not specified

Life expectancy:

• At least 5 days

Hematopoietic:

• See Disease Characteristics

• Hemodynamically stable with no hemodynamic compromise

Hepatic:

• AST or ALT no greater than 3 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases or other suspected bony processes)

• INR no greater than 1.6 (4.0 if receiving anticoagulants)

• No acute hepatitis or cirrhosis

Renal:

• Not specified

Other:

• Functioning central venous catheter in place

• No other condition or concurrent illness that would preclude study

• No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception other than or in addition to oral contraceptives

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior enrollment into this study

• No more than 48 hours since prior parenteral systemic antibacterial therapy for fever and neutropenia

• At least 14 days since prior investigational antibiotic or antifungal drugs

• Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a superficial fungal infection allowed

• No other concurrent investigational drugs, including antibiotics or antifungals

• No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or other antifungal treatments (except fluconazole)