Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transpla… (NCT00064311) | Clinical Trial Compass
CompletedPhase 1/2
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation
United StatesStarted 2003-06
Plain-language summary
RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Undergoing a non-myeloablative allogeneic hematopoietic stem cell transplantation
* Must be able to start prophylactic antifungal therapy within 48 hours of the transplantation chemotherapy preparative regimen and before the initiation of cyclosporine
* No diagnosis of deeply invasive fungal infection based on the MSG/EORTC criteria
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 5 times upper limit of normal (ULN)
* AST and ALT no greater than 5 times ULN
* Alkaline phosphatase no greater than 5 times ULN
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 4 weeks (12 weeks for males) after study participation
* Able to swallow oral medication
* Sufficient venous access
* No prior anaphylaxis attributed to the azole class of antifungals
* No concurrent medical condition that may create an unacceptable additional risk for the patient during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent hormonal contraceptives
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 2 weeks since other prior non-FDA approved investigational drugs
* No concurrent QTc prolonging medication (e.g., t…
Trial details
NCT IDNCT00064311
SponsorNational Institutes of Health Clinical Center (CC)