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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020527 |
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 | Intervention |
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Fever, Sweats, and Hot Flashes Infection Kidney Cancer Leukemia Lymphoma Neuroblastoma Neutropenia Sarcoma |
Drug: caspofungin acetate |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunocompromised with one or more of the following conditions:
No proven invasive fungal infection at time of study entry
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
Lombardi Cancer Center | |
Washington, District of Columbia, United States, 20007 | |
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) |
Study ID Numbers: | CDR0000068564, NCI-01-C-0084C |
Study First Received: | July 11, 2001 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00020527 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Anti-Infective Agents Neuroectodermal Tumors, Primitive Hot Flashes Urogenital Neoplasms Leukocyte Disorders Urologic Neoplasms Acute Myelocytic Leukemia Wilms' Tumor Leukemia, Promyelocytic, Acute Neuroepithelioma Kidney Diseases Hodgkin Disease Rhabdomyosarcoma Echinocandins Lymphoma, Large B-Cell, Diffuse |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Caspofungin Leukemia, Myeloid Carcinoma Neutropenia Neuroectodermal Tumors Malignant Mesenchymal Tumor Sarcoma Leukopenia Neoplasms, Glandular and Epithelial Acute Lymphoblastic Leukemia, Childhood Urinary Tract Neoplasm Leukemia, Lymphoid |
Anti-Infective Agents Neuroectodermal Tumors, Primitive Neoplasms, Nerve Tissue Hot Flashes Leukocyte Disorders Urogenital Neoplasms Body Temperature Changes Infection Urologic Neoplasms Neuroblastoma Fever Leukemia Signs and Symptoms Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Antifungal Agents Neoplasms, Germ Cell and Embryonal Kidney Diseases Lymphoma Echinocandins Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Caspofungin Agranulocytosis Pharmacologic Actions Carcinoma |