NCT00020527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

June 19, 2013

Status Verified

March 1, 2003

First QC Date

July 11, 2001

Last Update Submit

June 17, 2013

Conditions

Fever, Sweats, and Hot FlashesInfectionKidney CancerLeukemiaLymphomaNeuroblastomaNeutropeniaSarcoma

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood rhabdomyosarcomadisseminated neuroblastomarecurrent neuroblastomarecurrent Wilms tumor and other childhood kidney tumorsrecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiafever, sweats, and hot flasheschildhood acute promyelocytic leukemia (M3)recurrent/refractory childhood Hodgkin lymphomaneutropeniainfectionrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomapreviously treated childhood rhabdomyosarcoma

Interventions

caspofungin acetateDRUG

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

MeSH Terms

Conditions

FeverHot FlashesInfectionsKidney NeoplasmsLeukemiaLymphomaNeuroblastomaNeutropeniaSarcomaPrecursor Cell Lymphoblastic Leukemia-LymphomaWilms TumorRecurrenceBurkitt LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersNeoplasms, Connective and Soft TissueLeukemia, LymphoidNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Thomas J. Walsh, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Study Completion

June 1, 2003

Last Updated

June 19, 2013

Record last verified: 2003-03

Locations

US(5)