An interventional study of caspofungin acetate in Fever, Sweats, and Hot Flashes, Infection and Kidney Cancer, sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2013-06-19.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Supportive care
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.
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.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
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Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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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:
This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)