Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation

Phase

1/2

Condition

Platelet Disorders

Ovarian Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT00064311

030205

CDR0000315356

03-C-0205

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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., 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

Study Design

June 01, 2003

September 30, 2004

Study Description

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.

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.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Connect with a study center

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland 20892-1182
United States
Site Not Available

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