Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)

Study Overview
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Brief Summary
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This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.

Official Title
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A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia

Conditions
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Fungal Infection

Intervention / Treatment
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* Drug: caspofungin acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 3 to 24 months of age with one or more of the following conditions: Leukemia, lymphoma, or other cancers Bone marrow or peripheral stem transplantation High dose chemotherapy leading to a decrease in white blood cells Aplastic anemia Patient has an absolute neutrophil count <500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever > 38 degreesC (oral or oral equivalent) within 72 hours of screening. Exclusion Criteria: Patient is <3 months or >24 months of age at the time of study drug administration Patient has proven or probable invasive fungal infection at the time of enrollment Patient has certain blood clotting or liver function abnormalities Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>IV caspofungin acetate (50 mg/m²/day) | Drug: caspofungin acetate<br>* (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.<br>* Other names: CANCIDAS®;|
| Other: 2<br>IV caspofungin acetate (70 mg/m²/day) | Drug: caspofungin acetate<br>* (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.<br>* Other names: CANCIDAS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. |  | 28 Days |