Voriconazole to Treat Fungal Infections

March 3, 2008 updated by: National Cancer Institute (NCI)

An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections

Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients.

Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop.

Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy or that are unresponsive or intolerant to treatment with approved systemic antifungal agents. This trial is an extension of the Phase III multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 100 patients to be recruited from multiple centers. The patient population will consist of patients with proven deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents and currently on the voriconazole (99-C-0094) protocol. Voriconazole will be administered intravenously at 3-4 mg/kg q 12 hours or orally at 200-300 mg BID. Efficacy will be evaluated by clinical, radiological and microbiological response.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Males or (non-pregnant, lactating and nursing) females equal to or greater than 12 years of age.

Previous enrollment into and completion of voriconazole therapy in protocol 99-C-0094 investigating the use of voriconazole in the treatment of invasive fungal disease or empirical treatment of presumed fungal infections and enrolled within three weeks of completion of 99-C-0094B.

Clinical benefit was derived from previous voriconazole treatment.

Further clinical benefit is expected with extended voriconazole treatment.

Women of child bearing potential (or less than 2 years post- menopausal) must have a negative serum pregnancy test at baseline, and must agree to use barrier methods of contraception during the study.

Signed written informed consent must be obtained at protocol entry.

Assent will be obtained from minors capable of understanding.

Subjects must not have either ongoing serious adverse events probably related to voriconazole therapy or have ongoing adverse events probably related to voriconazole therapy which may pose a significant risk on continued therapy.

Must not have previously participated in this trial.

If receiving, must be able to discontinue the following drugs at least 24 hours prior to randomization: terfenadine, cisapride, and astemizole.

If receiving, must be able to discontinue sulphonylureas at least 24 hours prior to randomization.

Must not have received the following drugs within 14 days prior to randomization: rifampin, carbamazepine, or barbiturates.

Must not have AST, ALT, greater than 10 (upper limit normal).

Must not have serum creatinine greater than 3.0 mg/dl.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

July 1, 2001

Study Registration Dates

First Submitted

January 18, 2000

First Submitted That Met QC Criteria

December 9, 2002

First Posted (ESTIMATE)

December 10, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

November 1, 2000

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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