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Home > "V" Clinical Trials Conditions > Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy  Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
For Condition: Cancer,Neutropenia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Voriconazole may be effective in preventing systemicfungalinfections 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.
Details: 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 36 patients (18 per stratum) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/11 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Expected to develop neutropenia (absolute neutrophil count less than 500/mm - ) 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWalsh, Principal Investigator, Pediatric Oncology Branch
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-6359
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Jeffrey Blumer 216-844-3310
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Children's Hospital and Health Center, San Diego *Recruiting*
San Diego, California, 92123-4282
United States
Recruiting John Bradley 858-966-7785
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Antonio Arrieta 714-532-8403
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Hasan Jafri 214-648-3720
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Timothy Driscoll 919-668-1112
Additional Information:
Study ID Numbers: CDR0000316329; NCI-03-C-0218
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066599
Other Cancer Studies:
1. Treatment of neutropenic patients with fever who are suspected to have a gram positive infection (a specific kind of bacteria)
2. Anidulafungin in Treating Immunocompromised Children With Neutropenia
3. Screening for Hematology Branch Protocols
4. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
5. Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
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Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
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