Caspofungin Acetate in Treating Children With Fever and Neutropenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Neutropenia, Sarcoma

Intervention / Treatment
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* Drug: caspofungin acetate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: caspofungin acetate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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