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Caspofungin Acetate in Treating Children With Fever and Neutropenia

Primary Purpose

Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fever, Sweats, and Hot Flashes focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood rhabdomyosarcoma, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, fever, sweats, and hot flashes, childhood acute promyelocytic leukemia (M3), recurrent/refractory childhood Hodgkin lymphoma, neutropenia, infection, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, previously treated childhood rhabdomyosarcoma

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lombardi Cancer Center
  • Children's National Medical Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • St. Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
June 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020527
Brief Title
Caspofungin Acetate in Treating Children With Fever and Neutropenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Sweats, and Hot Flashes, Infection, Kidney Cancer, Leukemia, Lymphoma, Neuroblastoma, Neutropenia, Sarcoma
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood rhabdomyosarcoma, disseminated neuroblastoma, recurrent neuroblastoma, recurrent Wilms tumor and other childhood kidney tumors, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, fever, sweats, and hot flashes, childhood acute promyelocytic leukemia (M3), recurrent/refractory childhood Hodgkin lymphoma, neutropenia, infection, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, previously treated childhood rhabdomyosarcoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
caspofungin acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Walsh, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States

12. IPD Sharing Statement

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Caspofungin Acetate in Treating Children With Fever and Neutropenia

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