Anidulafungin in Treating Immunocompromised Children With Neutropenia

Infection Clinical Trial

Official title:

Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068471
• Other study ID #: CDR0000322888
• Secondary ID: NCI-03-C-0229C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 10, 2003
• Last updated: June 18, 2013
• Start date: July 2003
• Est. completion date: October 2007

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.

• Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.

OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).

Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.

Patients are followed at 7-9 days.

PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.

Other known NCT identifiers

• NCT00063466

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infection
• Neutropenia
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• anidulafungin

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Children's National Medical Center	Washington	District of Columbia
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,