Caspofungin Acetate in Treating Children With Fever and Neutropenia

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00020527

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma	Drug: caspofungin acetate	N/A

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 Design

Study Type:

Interventional

Primary Purpose:

Supportive Care

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 Start Date :

Mar 1, 2001

Actual Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
2	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
3	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
4	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
5	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794