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AzTrials

Kidney CancerPhase 2NCT00066599

Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

A Phase 2 study testing voriconazole in people with Kidney Cancer and Leukemia, run by National Cancer Institute (NCI) at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Kidney Cancer, Leukemia, Lymphoma
What is being tested?
voriconazole
How many people
Not given
Where
7 sitesUnited States
Study dates
Jun 2003to Jun 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Children's Hospital and Health Center, San Diego

    San Diego, California, 92123-4282

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
voriconazole
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
Medical subject headings
Kidney Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • voriconazoleDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066599
Sponsor's protocol ID
CDR0000316329
Other IDs
NCI-03-C-0218
Status last verified
Jul 2004
First submitted
6 Aug 2003
Last updated
19 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing voriconazole in people with Kidney Cancer and Leukemia, run by National Cancer Institute (NCI) at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.

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