|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068471 |
Purpose
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.
PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.
| Condition | Intervention | Phase |
|
Cancer-Related Problem/Condition Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: anidulafungin |
Phase I Phase II |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Anidulafungin |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label |
| Official Title: | Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.
Eligibility
| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Neutropenia due to cytotoxic chemotherapy or aplastic anemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents)
Contacts and Locations| United States, District of Columbia | |||||
| Children's National Medical Center | |||||
| Washington, District of Columbia, United States, 20010-2970 | |||||
| Lombardi Cancer Center at Georgetown University Medical Center | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| United States, North Carolina | |||||
| Duke Comprehensive Cancer Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, Tennessee | |||||
| St. Jude Children's Research Hospital | |||||
| Memphis, Tennessee, United States, 38105-2794 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Principal Investigator: | Thomas J. Walsh, MD | NCI - Pediatric Oncology Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000322888, NCI-03-C-0229C |
| First Received: | September 10, 2003 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068471 |
| Health Authority: | United States: Federal Government |
|
|
|
|