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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

Page last updated: August 20, 2015

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