Fever, Sweats, and Hot FlashesNCT00020527
Caspofungin Acetate in Treating Children With Fever and Neutropenia
A study testing caspofungin acetate in people with Fever, Sweats, and Hot Flashes and Infection, run by National Cancer Institute (NCI) at 5 sites in United States.
Trial summary
RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation. PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer
- What is being tested?
- caspofungin acetate
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Mar 2001to Jun 2003
- Phase
- Interventional
- 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:
- Immunocompromised with one or more of the following conditions:
- Leukemia, lymphoma, or other cancer
- Underwent bone marrow or peripheral blood stem cell transplantation
- Aplastic anemia
- Planned chemotherapy likely to incur more than 10 days of neutropenia
- Absolute neutrophil count no greater than 500/mm^3 AND at least 1 recorded fever over 38.0 ° C within 24 hours of study
- No proven invasive fungal infection at time of study entry
- Superficial fungal infection (e.g., cutaneous fungal infection, thrush, or candidal vaginitis) treatable with topical antifungals allowed
PATIENT CHARACTERISTICS:
Age:
- 2 to 17
Performance status:
- Not specified
Life expectancy:
- At least 5 days
Hematopoietic:
- See Disease Characteristics
- Hemodynamically stable with no hemodynamic compromise
Hepatic:
- AST or ALT no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN (unless related to bony metastases or other suspected bony processes)
- INR no greater than 1.6 (4.0 if receiving anticoagulants)
- No acute hepatitis or cirrhosis
Renal:
- Not specified
Other:
- Functioning central venous catheter in place
- No other condition or concurrent illness that would preclude study
- No prior allergy, hypersensitivity, or serious reaction to echinocandin antifungals
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception other than or in addition to oral contraceptives
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior enrollment into this study
- No more than 48 hours since prior parenteral systemic antibacterial therapy for fever and neutropenia
- At least 14 days since prior investigational antibiotic or antifungal drugs
- Concurrent topical antifungals (i.e., nystatin and/or azole formulations) for a superficial fungal infection allowed
- No other concurrent investigational drugs, including antibiotics or antifungals
- No concurrent rifampin, cyclosporine, phenytoin, carbamazapine, phenobarbital, or other antifungal treatments (except fluconazole)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Lombardi Cancer 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: A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia
RATIONALE: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.
PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.
Read the detailed description
OBJECTIVES:
- Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia.
- Determine the safety and tolerability of this drug in this patient population.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to age (2 to 11 vs 12 to 17).
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy, a breakthrough fungal infection, any deterioration of patient condition, or unacceptable toxicity.
Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels. Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1.
Patients are followed at 14 days.
PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum) will be accrued for this study.
- Conditions
- Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma
- Being tested
- caspofungin acetate
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood rhabdomyosarcoma, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, fever, sweats, and hot flashes, childhood acute promyelocytic leukemia (M3), recurrent/refractory childhood Hodgkin lymphoma, neutropenia, infection, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, previously treated childhood rhabdomyosarcoma
- Medical subject headings
- Fever, Hot Flashes, Infections, Kidney Neoplasms, Leukemia, Lymphoma, Neuroblastoma, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofungin acetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever, Sweats, and Hot FlashesStudies 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 N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Thomas J. Walsh, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020527
- Sponsor's protocol ID
- CDR0000068564
- Other IDs
- NCI-01-C-0084C
- Status last verified
- Mar 2003
- First submitted
- 11 Jul 2001
- 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
- A Multicenter, Open, Non-Comparative, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia
- ClinicalTrials.gov ID
- NCT00020527
- Acronym / sponsor ID
- CDR0000068564
- Conditions
- Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma
- Keywords
- recurrent childhood acute lymphoblastic leukemia, recurrent childhood rhabdomyosarcoma, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, fever, sweats, and hot flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Jun 2003 (actual)
- First posted
- 27 Jan 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: Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation.
PURPOSE: Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system.
Detailed description
OBJECTIVES:
- Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia.
- Determine the safety and tolerability of this drug in this patient population.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to age (2 to 11 vs 12 to 17).
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy, a breakthrough fungal infection, any deterioration of patient condition, or unacceptable toxicity.
Cohorts of 16 patients (8 per stratum) receive caspofungin acetate at 1 of 2 dose levels. Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1.
Patients are followed at 14 days.
PROJECTED ACCRUAL: A total of 32-64 patients (16 per dose level (cohort), 8 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
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 |
|---|---|---|
| caspofungin acetate | 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.
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 study chair
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 study testing caspofungin acetate in people with Fever, Sweats, and Hot Flashes and Infection, 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.
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.