Clinical trial · Interventional
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
A Multicenter, Double-Blind, Randomized, Comparative Study To Evaluate The Safety, Tolerability, And Efficacy Of MK-0991 Versus (Amphotericin B) Liposome For Injection As Empirical Therapy In Patients With Persistent Fever And Neutropenia
- 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: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects. PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caspofungin acetate | Drug | — | UNRESOLVED |
| liposomal amphotericin B | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation * Absolute neutrophil count less than 500/mm\^3 for past 96 hours and not expected to recover in next 48 hours * Received at least 96 hours of parenteral systemic antibacterial therapy * Fever greater than 38.0 degrees Celsius * Adequately managed bacterial infection allowed if all of the following are true: * Negative blood cultures * Received at least 5 days of antibiotics to which any bacterial isolates are sensitive * Surgical drainage of any abscess fluid or surgical debridement of infected tissues * Removal of infected catheters * No invasive fungal infection * Not previously enrolled on this study PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 30-100% Life expectancy: * At least 5 days Hematopoietic: * Platelet count at least 5,000/mm\^3 * INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants) Hepatic: * Bilirubin no greater than 3 times upper limit of normal (ULN) * AST or ALT no greater than 5 times ULN * Alkaline phosphatase no greater than 3 times ULN * No acute hepatitis or cirrhosis Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation * No other condition or illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * No concurrent investigational antineoplastic therapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 10 days since prior parenteral amphotericin B * At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug * No concurrent rifampin or cyclosporine * No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug * No concurrent alcohol
References
Publications (1)
- RESULTWalsh TJ, Teppler H, Donowitz GR, Maertens JA, Baden LR, Dmoszynska A, Cornely OA, Bourque MR, Lupinacci RJ, Sable CA, dePauw BE. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004 Sep 30;351(14):1391-402. doi: 10.1056/NEJMoa040446. PMID 15459300