InfectionPhase 1/2NCT00068471
Anidulafungin in Treating Immunocompromised Children With Neutropenia
A Phase 1/2 study testing anidulafungin in people with Infection and Neutropenia, run by National Cancer Institute (NCI) at 5 sites in United States.
Trial summary
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia. PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- anidulafungin
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Jul 2003to Oct 2007
- Phase
- Phase 1/2
- 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 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Neutropenia due to cytotoxic chemotherapy or aplastic anemia
- Duration expected to be 10 days
- Absolute neutrophil count less than 500/mm^3 OR less than 1,000/mm^3 and expected to fall below 500/mm^3 within 72 hours
- No deeply invasive fungal infection confirmed prior to study entry
PATIENT CHARACTERISTICS:
Age
- 2 to 17
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- AST or ALT no greater than 5 times upper limit of normal (ULN)
- Bilirubin no greater than 2.5 times ULN
Renal
- Creatinine clearance at least 30 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 30 days after study participation
- No prior anaphylaxis attributed to the echinocandin class of antifungals
- No other concurrent medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 4 weeks since prior investigational drugs
- No prior participation in this clinical trial
- No prior anidulafungin
- No other concurrent investigational drugs
- No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents)
- Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed
- Concurrent broad-spectrum antibiotics allowed
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.
PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.
Read the detailed description
OBJECTIVES:
- Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.
- Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.
- Being tested
- anidulafungin
- Keywords
- infection, neutropenia, unspecified childhood solid tumor, protocol specific
- Medical subject headings
- Infections, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anidulafunginDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJul 2003
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Supportive care
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas J. Walsh, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068471
- Sponsor's protocol ID
- CDR0000322888
- Other IDs
- NCI-03-C-0229C
- Status last verified
- Apr 2004
- First submitted
- 10 Sep 2003
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
- ClinicalTrials.gov ID
- NCT00068471
- Acronym / sponsor ID
- CDR0000322888
- Keywords
- infection, neutropenia, unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2003
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.
PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.
Detailed description
OBJECTIVES:
- Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.
- Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.
Study design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anidulafungin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Walsh, MD principal investigator
National Cancer Institute (NCI)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anidulafungin in people with Infection and Neutropenia, run by National Cancer Institute (NCI) at 5 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 5 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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.