Anidulafungin in Treating Immunocompromised Children With Neutropenia

NCT00068471 | Completed Phase 1

• 2 other identifiers: CDR0000322888NCI-03-C-0229C
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia. PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.

Conditions

Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

infection; neutropenia; unspecified childhood solid tumor, protocol specific

Interventions

anidulafungin DRUG

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Neutropenia due to cytotoxic chemotherapy or aplastic anemia * Duration expected to be 10 days * Absolute neutrophil count less than 500/mm\^3 OR less than 1,000/mm\^3 and expected to fall below 500/mm\^3 within 72 hours * No deeply invasive fungal infection confirmed prior to study entry PATIENT CHARACTERISTICS: Age * 2 to 17 Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * AST or ALT no greater than 5 times upper limit of normal (ULN) * Bilirubin no greater than 2.5 times ULN Renal * Creatinine clearance at least 30 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 30 days after study participation * No prior anaphylaxis attributed to the echinocandin class of antifungals * No other concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since prior investigational drugs * No prior participation in this clinical trial * No prior anidulafungin * No other concurrent investigational drugs * No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents) * Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed * Concurrent broad-spectrum antibiotics allowed

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

Lombardi Cancer Center at Georgetown University Medical 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

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

MeSH Terms

Conditions

Infections; Neutropenia

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas J. Walsh, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: July 1, 2003
• Study Completion: October 1, 2007
• Last Updated: June 19, 2013

Record last verified: 2004-04

Locations

US (5)