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


Phase 1/Phase 2
2 Years
17 Years
Not Enrolling
Both
Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Thomas J. Walsh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000322888

NCT ID:

NCT00068471

Start Date:

July 2003

Completion Date:

October 2007

Related Keywords:

  • Infection
  • Neutropenia
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • infection
  • neutropenia
  • unspecified childhood solid tumor, protocol specific
  • Neutropenia

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Children's National Medical CenterWashington, District of Columbia  20010-2970
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182