Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066599
First received: August 6, 2003
Last updated: June 18, 2013
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Neuroblastoma
Neutropenia
Sarcoma
Drug: voriconazole
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2003
Study Completion Date: June 2004
Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066599

Locations
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
Children's Hospital and Health Center, San Diego
San Diego, California, United States, 92123-4282
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00066599     History of Changes
Obsolete Identifiers: NCT00062920
Other Study ID Numbers: CDR0000316329, NCI-03-C-0218
Study First Received: August 6, 2003
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neutropenia
recurrent childhood lymphoblastic lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
stage I childhood small noncleaved cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage IV childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
stage I childhood large cell lymphoma
stage II childhood large cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
recurrent/refractory childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
childhood acute promyelocytic leukemia (M3)
previously treated childhood rhabdomyosarcoma
recurrent Wilms tumor and other childhood kidney tumors
recurrent childhood rhabdomyosarcoma
childhood chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Mycoses
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neuroblastoma
Neutropenia
Lymphoma, Non-Hodgkin
Sarcoma
Myelodysplastic-Myeloproliferative Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014