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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066599 |
Purpose
RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Neutropenia Sarcoma |
Drug: voriconazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label |
| Official Title: | An Open-Label, Intravenous To Oral Switch, Multiple Dose, Multi-Center Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Hospitalized Children Aged 2 - <12 Years Who Require Treatment For The Prevention Of Systemic Fungal Infection |
| Study Start Date: | June 2003 |
OBJECTIVES:
OUTLINE: This is a pilot, open-label, multicenter study. Patients are stratified according to age (2 to 5 vs 6 to 11).
Within 48 hours after completion of chemotherapy, patients begin prophylactic therapy:
Depending on the results of the interim pharmacokinetic analysis, the last 18 patients entered on the study receive 1 of the following regimens:
NOTE: *Patients who are unable to tolerate oral medication may continue receiving IV medication until day 20.
In all cohorts, treatment continues until blood counts recover or day 30 in the absence of unacceptable toxicity or progression of infection.
Patients are followed at 30 days and at 12 months.
PROJECTED ACCRUAL: A total of 49 patients (approximately 24 per stratum) were accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Expected to develop neutropenia (absolute neutrophil count less than 500/mm^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 24 hours since prior use of any of the following:
More than 14 days since prior use of any of the following:
No concurrent use of any of the following:
No other concurrent investigational drugs except any of the following:
Contacts and Locations| United States, California | |
| Children's Hospital and Health Center, San Diego | |
| San Diego, California, United States, 92123-4282 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| 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, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104-4318 | |
| United States, Texas | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: | Thomas J. Walsh, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000316329, NCI-03-C-0218 |
| Study First Received: | August 6, 2003 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066599 History of Changes |
| Health Authority: | United States: Federal Government |
|
neutropenia recurrent childhood lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma stage I childhood small noncleaved cell lymphoma stage II childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma stage I childhood large cell lymphoma stage II childhood large cell lymphoma stage III childhood large cell lymphoma |
stage IV childhood large cell lymphoma childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies recurrent/refractory childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma childhood acute promyelocytic leukemia (M3) previously treated childhood rhabdomyosarcoma recurrent Wilms tumor and other childhood kidney tumors recurrent childhood rhabdomyosarcoma childhood chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia |
|
Anti-Infective Agents Neuroectodermal Tumors, Primitive Urogenital Neoplasms Leukocyte Disorders Urologic Neoplasms Neoplasms, Connective and Soft Tissue Mycoses Preleukemia Pathologic Processes Neoplasms by Site Hemorrhagic Disorders Therapeutic Uses Voriconazole Cardiovascular Diseases Kidney Diseases |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Carcinoma Multiple Myeloma Neutropenia Neuroectodermal Tumors Neoplasms Sarcoma Lymphoma, Non-Hodgkin Neoplasms, Neuroepithelial Leukopenia Neoplasms, Glandular and Epithelial Precancerous Conditions |
