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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)

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

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