- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020527
Caspofungin Acetate in Treating Children With Fever and Neutropenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Tennessee
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Memphis, Tennessee, United States, 38105-2794
- St. Jude Children's Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas J. Walsh, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- infection
- neutropenia
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- fever, sweats, and hot flashes
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent childhood lymphoblastic lymphoma
- recurrent Wilms tumor and other childhood kidney tumors
- childhood acute promyelocytic leukemia (M3)
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Hematologic Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Neuroectodermal Tumors, Primitive
- Body Temperature Changes
- Neuroectodermal Tumors, Primitive, Peripheral
- Lymphoma
- Kidney Neoplasms
- Leukemia
- Neutropenia
- Fever
- Hot Flashes
- Neuroblastoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antifungal Agents
- Caspofungin
Other Study ID Numbers
- CDR0000068564
- NCI-01-C-0084C
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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