Caspofungin Acetate in Treating Children With Fever and Neutropenia

N/ACompletedNCT00020527

National Cancer Institute (NCI)

Overview

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.

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

INTERVENTIONAL

Purpose

SUPPORTIVE_CARE

Conditions

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

Interventions

caspofungin acetateDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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 (5)

Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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