Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy (NCT00066599) | Clinical Trial Compass
CompletedPhase 2
Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
United StatesStarted 2003-06
Plain-language summary
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.
Who can participate
Age range
2 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.