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Home > "I" Clinical Trials Conditions > Investigating Voriconazole to Prevent Systemic Fungal Infection  Investigating Voriconazole to Prevent Systemic Fungal Infection
Investigating Voriconazole to Prevent Systemic Fungal Infection
For Condition: Lymphoma,Neutropenia,Aplastic Anemia,Leukemia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Children with a decreased ability to fight infection are at high risk for developing fungal infections. At present there are few medicines for treating fungal infections in children. Voriconazole is a new drug that is FDA approved to treat fungal infections in adults. The purpose of this study is to determine the safety, tolerability and pharmacokinetics (the body's handling of the drug) when it is given intravenously and orally to children younger than 12. Thirty-six children younger than 12 will participate in this study. Study participants will undergo the following evaluations: a physical exam, including an eye exam and an electrocardiogram; blood tests; and urinalysis. Participants will receive one or more different dosages of voriconazole intravenously, depending on when they enroll in the study. At the end of IV therapy, they will receive the drug as an oral solution two times a day. Investigators will obtain blood samples from participants on day 4, 8 and 12. Participants will remain hospitalized through day 8 of the study. On day 12, participants will undergo repeat evaluations from the beginning of the study. Their participation in this study will be last up to a maximum of 30 days. There will be two follow-up visits: at one month and at one year.
Details: The objective of this study is to evaluate the safety, tolerability and pharmacokinetics of intravenous and oral voriconazole at two dosage levels in an immunocompromised pediatric patient population. The plasma concentrations of the major metabolite of voriconazole (N-Oxide) in these patients will be performed. The study is designed as a multi-center, open-label, multiple dose study of intravenous and oral voriconazole. Intravenous voriconazole will be administered prophylactically twice daily to immunocompromised children at high risk for invasive mycoses. The patient population consists of children aged 2 to less than 12 years; two age groups will be studied (2 to less than 6, 6 to less than 12). The planned sample size is 36 children with 18 children in each cohort. For those children who do not complete 4 days of oral dosing, a replacement patient will be added. Immunocompromised children at high risk for invasive mycoses will receive voriconazole prophylactically. Therapy will be initiated within 48 hours after completion of chemotherapy. Voriconazole therapy will continue until recovery from neutropenia. Children in the first cohort will initially receive a loading dose of 6 mg/kg IV q12h X 2 doses followed by 4 mg/kg q 12h through Day 4 of therapy. On day 5, patients will receive 6 mg/kg q 12h through Day 8. On Day 9, patients will be switched to an oral solution of voriconazole at a dosage of 4 mg/kg q 12h. If the patient is unable to take oral medication on day 9, IV treatment may continue up to day 20. Pharmacokinetics will be obtained on the fourth day of oral therapy. An interim analysis will be performed and if the median AUC (tau) of voriconazole in the first 12 patients following 6 mg/kg q 12h dosing is less than 40,000ng.hr/mL and there are no safety concerns, the remaining 18 patients will receive voriconazole after Day 4 at a dosage of 8 mg/kg. If the median AUC (tau) of voriconazole in the first 12 patients following 6 mg/kg q 12h dosing is more than 40,000.hr/mL and there are no safety concerns, the remaining 18 patients will be dosed at 5mg/kg q 12h. Twelve-hour pharmacokinetics will be collected on Days 4, 8 and 12 of therapy in both dosage cohorts.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: a. Children aged from 2 to less than 12 years who require treatment for the prevention of systemic fungal infection, and who can tolerate being switched to oral therapy between Days 9 and 20 in Cohort I and II A, or Days 5 to 20 in Cohort IIB. b. Children who are expected to develop neutropenia (ANC less than 500 cells/mm(3)) lasting for more than 10 days following chemotherapy for of the following conditions: i. Leukemia ii. Lymphoma iii. Aplastic Anemia iv. As the preparative regimen for bone marrow or stem cell transplantation. c. Patients who are anticipated to live more than 3 months. d. Females of childbearing potential (post-menarchal) must have a negative pregnancy test at entry. e. Informed consent of the parent or legally authorized representative must be obtained prior to entry. f. Assent will be obtained from minors capable of understanding. EXCLUSION CRITERIA: a. Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to study start or if they need to commence any of the following during the study: terfenadine, pimozide, quinidine, astemizole, and cisapride (due to the possibility of QTc prolongation with these drugs) and omeprazole (an inhibitor of CYP2C19, CYP2C9, and in lesser extent CYP3A4 isoenzymes) which is known to increase plasma voriconazole levels and ergot alkaloids. b. Patients who have received the following drugs within 14 days prior to study entry: rifampicin, rifampin, rifabutin, carbamazepine, phenytoin, nevirapine and long acting barbiturates as these are inducers of hepatic enzymes and may result in undetectable levels of voriconazole. c. Patients who have received sirolimus, as voriconazole is known to increase significantly sirolimus blood levels. d. Severe hypokalemia (less than 3.2 mmol/L). Potassium may be corrected to a level greater than 3.2 mmol/L to enroll patient onto study. e. Patients who are taking or are likely to receive any investigational drugs except those used for treatment of a child's cancer, antiretroviral agents and drugs used for treatments of any AIDS defining opportunistic infections, all of which are allowed. f. Patients who are enrolled in investigational anticancer drug trials that exclude the use of other investigational agents should not be enrolled in this study. g. Patients with a history or hypersensitivity to or severe intolerance of azole antifungal agents. h. Patients who have already been entered onto this voriconazole protocol once. i. Patients with a medical history or current evidence of cardiac arrhythmia. j. Patients with an AST, ALT or total bilirubin greater than 5 X ULN. k. Patients with moderate and severe renal impairment (i.e., calculated creatinine clearance less than 30mL/min). Creatinine clearance will be calculated using the following equation: 0.55 X height (cm)/serum creatinine (mg/dL). l. Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030218; 03-C-0218
Study Start Date: June 13, 2003
Record last reviewed: June 10, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062920
Other Neutropenia Studies:
1. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
2. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
3. Comparison of Antibody Therapies in Treating Patients With Graft- Versus-Host Disease That Does Not Respond to Steroid Therapy
4. Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
5. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
Related Studies:
Other Neutropenia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Investigating Voriconazole to Prevent Systemic Fungal Infection
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