Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00292071
First received: February 14, 2006
Last updated: October 26, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Fungal Infection
Drug: caspofungin acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®
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®

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292071

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00292071     History of Changes
Other Study ID Numbers: 2005_099, MK0991-042
Study First Received: February 14, 2006
Last Updated: October 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Caspofungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014