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Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020527 |
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.
Condition | Intervention |
Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma |
Drug: caspofungin acetate |
MedlinePlus related topics: | Cancer Fever Kidney Cancer Leukemia, Childhood Lymphoma Neuroblastoma Soft Tissue Sarcoma Sweat |
ChemIDplus related topics: | Caspofungin Caspofungin Acetate |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | 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 |
Study Start Date: | March 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to age (2 to 11 vs 12 to 17).
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy, a breakthrough fungal infection, any deterioration of patient condition, or unacceptable toxicity.
Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels. Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1.
Patients are followed at 14 days.
PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum) will be accrued for this study.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunocompromised with one or more of the following conditions:
No proven invasive fungal infection at time of study entry
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |||||
Children's National Medical Center | |||||
Washington, District of Columbia, United States, 20010-2970 | |||||
Lombardi Cancer Center | |||||
Washington, District of Columbia, United States, 20007 | |||||
United States, Maryland | |||||
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
Baltimore, Maryland, United States, 21231-2410 | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 | |||||
United States, Tennessee | |||||
St. Jude Children's Research Hospital | |||||
Memphis, Tennessee, United States, 38105-2794 |
Study Chair: | Thomas J. Walsh, MD | National Cancer Institute (NCI) |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068564, NCI-01-C-0084C |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020527 |
Health Authority: | United States: Federal Government |
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