Caspofungin Acetate in Treating Children With Fever and Neutropenia - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020527

Purpose

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	Intervention
Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma	Drug: caspofungin acetate

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: acute promyelocytic leukemia cyclic neutropenia neuroblastoma

MedlinePlus related topics: Cancer Fever Kidney Cancer Leukemia Lymphoma Neuroblastoma Soft Tissue Sarcoma Sweat

Drug Information available for: Caspofungin Caspofungin Acetate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2001

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

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020527

Locations

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Thomas J. Walsh, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00020527 History of Changes
Obsolete Identifiers:	NCT00011219
Other Study ID Numbers:	CDR0000068564, NCI-01-C-0084C
Study First Received:	July 11, 2001
Last Updated:	May 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Fever
Leukemia
Lymphoma
Neuroblastoma
Neutropenia
Hot Flashes
Sarcoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms

Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Body Temperature Changes
Signs and Symptoms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on February 12, 2012