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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00292071
Collaborator
(none)
16
Enrollment
2
Arms
26
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: caspofungin acetate
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Jul 1, 2006
Actual Study Completion Date :
Jul 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Other: 1

IV caspofungin acetate (50 mg/m²/day)

Drug: caspofungin acetate
(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.
Other Names:
  • MK0991
  • CANCIDAS®

    		•
    Other: 2

    IV caspofungin acetate (70 mg/m²/day)

    Drug: caspofungin acetate
    (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.
    Other Names:
  • MK0991
  • CANCIDAS®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [28 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00292071
    Other Study ID Numbers:
    • 0991-042
    • MK0991-042
    • 2005_099
    First Posted:
    Feb 15, 2006
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Mycoses
    Neutropenia
    Caspofungin

    Study Results

    No Results Posted as of Feb 23, 2017