A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia

Inclusion 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)