Clinical trial · Interventional
Caspofungin Acetate in Treating Children With Fever and Neutropenia
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
NCT00020527CI-TRIAL-00010833completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever, Sweats, and Hot Flashes | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caspofungin acetate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.