Caspofungin Acetate in Treating Children With Fever and Neutropenia
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever, Sweats, and Hot Flashes; Infection; Kidney Cancer; Leukemia; Lymphoma; Neuroblastoma; Neutropenia; Sarcoma
Intervention: caspofungin acetate (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Thomas J. Walsh, MD, Study Chair, Affiliation: National Cancer Institute (NCI)
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 system.
Clinical Details
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
Study design: Primary Purpose: Supportive Care
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Children's National Medical Center, Washington, District of Columbia 20010-2970, United States
Lombardi Cancer Center, Washington, District of Columbia 20007, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
St. Jude Children's Research Hospital, Memphis, Tennessee 38105-2794, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2001
Last updated: June 17, 2013
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