Caspofungin Acetate in Treating Children With Fever and Neutropenia

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020527
• Other study ID #: CDR0000068564
• Secondary ID: NCI-01-C-0084C
• Status: Completed
• Phase: N/A
• First received: July 11, 2001
• Last updated: June 17, 2013
• Start date: March 2001
• Est. completion date: June 2003

Study information

• Verified date: March 2003
• 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: 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.

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.

Other known NCT identifiers

• NCT00011219

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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)

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fever
• Fever, Sweats, and Hot Flashes
• Hot Flashes
• Infection
• Kidney Cancer
• Leukemia
• Lymphoma
• Neuroblastoma
• Neutropenia
• Sarcoma

Intervention

Drug:
• caspofungin acetate

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
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	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,