Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066599
First received: August 6, 2003
Last updated: May 14, 2011
Last verified: July 2004
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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 Neoplasms Neuroblastoma Neutropenia Sarcoma |
Drug: voriconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
cyclic neutropenia
familial acute myeloid leukemia with mutated CEBPA
neuroblastoma
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Kidney Cancer
Leukemia
Lymphoma
Molds
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Soft Tissue Sarcoma
Drug Information available for:
Voriconazole
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | June 2003 |
OBJECTIVES:
- Determine the pharmacokinetics of voriconazole administered IV and orally for the prevention of systemic fungal infection in pediatric patients with neutropenia after chemotherapy.
- Determine the safety and tolerability of this drug in these patients.
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:
- Cohort 1 (the first 18 patients, 9 per stratum): Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-8 and oral voriconazole* twice daily beginning on day 9.
Depending on the results of the interim pharmacokinetic analysis, the last 18 patients entered on the study receive 1 of the following regimens:
- Cohort 2A:Patients receive voriconazole as in cohort 1 at a higher dose.
- Cohort 2B: Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-4 and oral voriconazole* twice daily beginning on day 5.
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 |
Criteria
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:
- Leukemia
- Lymphoma
- Aplastic anemia
- Preparation for a bone marrow or stem cell transplantation
- Requiring treatment for the prevention of systemic fungal infection
PATIENT CHARACTERISTICS:
Age
- 2 to 11
Performance status
- Not specified
Life expectancy
- More than 3 months
Hematopoietic
- See Disease Characteristics
Hepatic
- AST and ALT no greater than 5 times upper limit of normal (ULN)
- Bilirubin no greater than 5 times ULN
Renal
- Creatinine clearance at least 30 mL/min
Cardiovascular
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- No severe hypokalemia (potassium less than 3.2 mmol/L)
- No prior hypersensitivity to or severe intolerance of azole antifungal agents
- No other concurrent condition that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
At least 24 hours since prior use of any of the following:
- Terfenadine
- Pimozide
- Quinidine
- Astemizole
- Cisapride
- Omeprazole
More than 14 days since prior use of any of the following:
- Rifampin
- Rifabutin
- Carbamazepine
- Phenytoin
- Nevirapine
- Long-acting barbiturates
- No prior sirolimus
- No prior enrollment on this study
No concurrent use of any of the following:
- Terfenadine
- Pimozide
- Quinidine
- Astemizole
- Cisapride
- Omeprazole
No other concurrent investigational drugs except any of the following:
- Drugs used as treatment for cancer
- Antiretroviral agents
- Drugs used for the treatment of any AIDS-defining opportunistic infections
- No concurrent enrollment in investigational anticancer drug trials that exclude the use of other investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066599
Locations
| United States, California | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Children's Hospital and Health Center, San Diego | |
| San Diego, California, United States, 92123-4282 | |
| 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 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Thomas J. Walsh, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00066599 History of Changes |
| Obsolete Identifiers: | NCT00062920 |
| Other Study ID Numbers: | CDR0000316329, NCI-03-C-0218 |
| Study First Received: | August 6, 2003 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Mycoses Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neuroblastoma Neutropenia Lymphoma, Non-Hodgkin |
Sarcoma Myelodysplastic-Myeloproliferative Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013