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, France, Germany171 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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