Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients … (NCT00110045) | Clinical Trial Compass
CompletedPhase 2
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
Belgium, France171 participantsStarted 2005-02
Plain-language summary
RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.
PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of proven or probable invasive aspergillosis (IA)
* Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry
* Meets any of the following criteria:
* Diagnosis of a hematologic malignancy
* Underwent autologous or allogeneic hematopoietic stem cell transplantation
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 20-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* AST and ALT ≤ 5 times upper limit of normal (ULN)
* Bilirubin ≤ 5 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* No severe hepatic insufficiency
* Child-Pugh score ≤ 9
Renal
* No severe renal failure requiring hemodialysis or peritoneal dialysis
* Creatinine \< 3.4 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception
* No known HIV positivity
* No history of allergy or adverse reaction to echinocandin drugs
* No known bacterial infection that is not adequately treated
* No psychological, familial, social, or geographical condition that would preclude study participation or compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not…
What they're measuring
1
Response rate as assessed by standard criteria after completion of study treatment
Trial details
NCT IDNCT00110045
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC