Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066599
• Other study ID #: CDR0000316329
• Secondary ID: NCI-03-C-0218
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2003
• Last updated: June 18, 2013
• Start date: June 2003
• Est. completion date: June 2004

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Other known NCT identifiers

• NCT00062920

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Kidney Cancer
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Mycoses
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Neuroblastoma
• Neutropenia
• Plasmacytoma
• Preleukemia
• Sarcoma

Intervention

Drug:
• voriconazole

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital and Health Center, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,