Caspofungin Acetate in Treating Children With Fever and Neutropenia
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| ClinicalTrials.gov Identifier: NCT00020527 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma | Drug: caspofungin acetate | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Supportive Care |
| 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 Start Date : | March 2001 |
| Actual Study Completion Date : | June 2003 |
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| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020527
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Study Chair: | Thomas J. Walsh, MD | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020527 |
| Obsolete Identifiers: | NCT00011219 |
| Other Study ID Numbers: |
CDR0000068564 NCI-01-C-0084C |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 19, 2013 |
| Last Verified: | March 2003 |
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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 |
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Lymphoma Leukemia Neuroblastoma Kidney Neoplasms Neutropenia Fever Hot Flashes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive |
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Body Temperature Changes Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |