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

Objectives

1. Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation.
2. 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.
3. Determine the effect of this drug on concurrently administered cyclosporine in these patients.
4. 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

• 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., 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

• 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

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		Ph: 301-402-0023

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

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