| Phase I/II Study of Ravuconazole for the Prevention of Invasive Fungal Infections in Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II, Phase I | Supportive care | Closed | 18 and over | NCI-03-C-0205
NCT00064311 |
Objectives - Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation.
- Determine the pharmacokinetics and efficacy of this drug, in terms of frequency of breakthrough fungal infections and requirement for empirical antifungal therapy, in these patients.
- Determine the effect of this drug on concurrently administered cyclosporine in these patients.
- Determine the pharmacokinetics of this drug with and without cyclosporine in these patients.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy - See Disease Characteristics
Chemotherapy Endocrine therapy - No concurrent hormonal contraceptives
Radiotherapy Surgery Other - At least 2 weeks since other prior non-FDA approved investigational drugs
- No concurrent QTc prolonging medication (e.g., terfenadine, cisapride, quinidine, pimozide, or dofetilide)
- No concurrent rifampin
- No other concurrent experimental or systemic antifungal therapy
- No concurrent agents containing amphotericin B
- No other concurrent systemic azole or triazole antifungal agents
- No concurrent echinocandins
- Concurrent topical antifungals allowed
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic 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 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
Expected Enrollment A total of 24 patients will be accrued for this study. Outline This is an open-label, dose-escalation study. Patients receive oral ravuconazole once daily beginning within 48 hours of the chemotherapy preparative regimen and before the initiation of cyclosporine. Treatment continues until blood counts recover in the absence of unacceptable toxicity. Cohorts of 8 patients receive escalating doses of ravuconazole until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 4 weeks.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research  | | | | Thomas Walsh, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase I-II Safety, Tolerability And Pharmacokinetic Study Of Ravuconazole For Prophylaxis Of Invasive Fungal Infections In Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation | | | Trial Start Date | | 2003-06-02 | | | Registered in ClinicalTrials.gov | | NCT00064311 | | | Date Submitted to PDQ | | 2003-06-02 | | | Information Last Verified | | 2004-07-09 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
