Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Completed 2 to 11 NCI NCI-03-C-0218 NCT00066599

Objectives

1. Determine the pharmacokinetics of voriconazole administered IV and orally for the prevention of systemic fungal infection in pediatric patients with neutropenia after chemotherapy.
2. Determine the safety and tolerability of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Expected to develop neutropenia (absolute neutrophil count less than 500/mm³) 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

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

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

Expected Enrollment

A total of 49 patients (approximately 24 per stratum) were accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Thomas Walsh, MD, Principal investigator		Ph: 301-402-0023

Registry Information
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
Trial Start Date		2003-06-25
Registered in ClinicalTrials.gov		NCT00066599
Date Submitted to PDQ		2003-06-18
Information Last Verified		2004-07-09

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