Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
Condition: Kidney Cancer; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neuroblastoma; Neutropenia; Sarcoma
MeSH terms: Mycoses; Lymphoma; Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Neuroblastoma; Plasmacytoma; Myelodysplastic Syndromes; Neutropenia; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): voriconazole
Intervention type(s): Drug
Intervention MeSH terms: Voriconazole
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 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; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; meningeal chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; intraocular lymphoma; primary central nervous system non-Hodgkin lymphoma; recurrent adult T-cell leukemia/lymphoma; acute undifferentiated leukemia; childhood acute lymphoblastic leukemia in remission; recurrent childhood acute lymphoblastic leukemia; secondary acute myeloid leukemia; untreated childhood acute lymphoblastic leukemia; disseminated neuroblastoma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent neuroblastoma; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable