Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00079222
First received: March 8, 2004
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.

PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.


Condition Intervention
Cancer
Drug: itraconazole
Drug: voriconazole

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Randomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia, Childhood Acute Non Lymphoblastic Leukemia B-cell Lymphomas Burkitt Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Follicular Lymphoma Gestational Trophoblastic Tumor Hairy Cell Leukemia Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Hypereosinophilic Syndrome Juvenile Myelomonocytic Leukemia Kidney Cancer Leukemia, B-cell, Chronic Leukemia, Myeloid Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Neuroblastoma Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Plasmablastic Lymphoma Renal Cancer Sezary Syndrome Small Non-cleaved Cell Lymphoma Testicular Cancer Wilms' Tumor
U.S. FDA Resources

Further study details as provided by Jonsson Comprehensive Cancer Center:

Study Start Date: November 2003
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation.

OUTLINE: This is a randomized study. Patients are stratified according to donor type (related vs unrelated). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT), patients receive voriconazole IV twice daily on days 1-14 and then orally* twice daily on days 15-100.
  • Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days 1-2, once daily on days 3-14, and then orally* twice daily on days 15-100.

NOTE: *Patients unable to tolerate oral medication may continue IV medication beyond day 14.

In both arms, treatment continues in the absence of unacceptable toxicity or an invasive fungal infection. Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100.

Patients are followed until day 180 post-transplantation.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing allogeneic hematopoietic stem cell transplantation
  • No invasive yeast infection within the past 8 weeks

    • Colonized or superficial infection allowed
  • No documented or probable aspergillus or mold infection within the past 8 weeks
  • Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia

PATIENT CHARACTERISTICS:

Age

  • 12 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 1 week since prior amphotericin B or fluconazole for candidemia
  • No concurrent therapy with any of the following:

    • Rifampin
    • Rifabutin
    • Phenobarbital
    • Phenytoin
    • Carbamazepine
    • Oral midazolam
    • Triazolam
    • Terfenadine
    • Astemizole
  • Concurrent topical antifungal agents for superficial fungal infections allowed
  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: NCT00079222

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Mary C. Territo, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Mary Territo, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00079222     History of Changes
Other Study ID Numbers: CDR0000355116, P30CA016042, UCLA-0307071
Study First Received: March 8, 2004
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
infection
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
refractory chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
accelerated phase chronic myelogenous leukemia
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
previously treated myelodysplastic syndromes
chronic eosinophilic leukemia
primary myelofibrosis

Additional relevant MeSH terms:
Hydroxyitraconazole
Itraconazole
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014