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Home > "T" Clinical Trials Conditions > The Use of Ravuconazole to Prevent Fungal Infections in Bone Marrow Transplant Patients  The Use of Ravuconazole to Prevent Fungal Infections in Bone Marrow Transplant Patients
The Use of Ravuconazole to Prevent Fungal Infections in Bone Marrow Transplant Patients
For Condition: Hematopoietic Stem Cell Transplantation
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: A fungal infection can be life-threatening to the bone marrow transplant (BMT) patient. The only preventive treatment is the drug fluconazole. The new drug ravuconazole is effective against more types of fungal infections than fluconazole. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (the way the body handles a drug) of ravuconazole. It is hoped that this study will lead to the development of a safe and effective medication for the prevention of fungal infections. Twenty-four BMT patients will participate in the study. Each will take a pill once daily. Three groups of eight patients will take one of three dosage levels of ravuconazole (400mg, 600mg, or 800mg). Patients will start taking ravuconazole within 48 hours of their BMT chemotherapy preparative regimen. Participants will have blood drawn periodically to measure drug levels and to check for side effects. At least 72 hours prior to their first dosage, participants will undergo the following evaluations: a physical exam, chest x-ray, pregnancy test (for women of childbearing potential), blood work, and urine tests.
Details: The objective of this study is to evaluate the safety, tolerability and plasma pharmacokinetics of ravuconazole as prophylaxis in a non-myeloblative allogeneic hematopoietic stem cell transplant population. The trial is designed as an open-label, single-center, dose escalation study with a planned sample size of 24 patients. The study will consist of three dosing cohorts of 400mg, 600mg and 800mg to be administered orally once daily. There will be eight patients in each cohort. If an individual patient does not complete the full pharmacokinetic course for reasons other than study drug related toxicity (e.g., early discharge), a replacement patient may be enrolled for a total possible sample size of 48 patients. Antifungal therapy will be initiated within 48 hours of their transplant chemotherapy preparative regimen (and prior to the initiation of cyclosporine) and will continue to within 48 hours after recovery from neutropenia (defined as an absolute neutrophil count (ANC) of greater than or equal to 250/mm(3)). Ravuconazole will be administered with food at approximately 8am daily and dietary intake at the time of the daily ravuconazole dose will be collected. Pharmacokinetics (PK) will be obtained on the first day and the last day of ravuconazole dosing, and trough PK samples will be collected on Days 7, 14, 17, 19 and 21. Cyclosporine will be initiated per the patients' primary transplant protocols between Days -4 and -1 of receipt of stem cells. Cyclosporine serum levels will be drawn twice weekly per the patients' primary protocols and on days 7, 14, 17, 19, and 21 to correspond with ravuconazole trough levels. Cyclosporine serum levels will be maintained between 150-400ng/mL based on the prescribed parameters in the patients' primary transplant protocols.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. Informed consent of the patient or legally authorized representative must be obtained prior to entry. 2. Patients may be of either gender. 3. Women of Childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication. (WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea greater than or equal to 12 consecutive months]; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level greater than 35mIU/mL. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (e.g., diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of childbearing potential). 4. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after study completion in such a manner that the risk of pregnancy is minimized. 5. Patients greater than or equal to 18 years of age. 6. Patients undergoing a non-myeloablative allogeneic hematopoietic stem cell transplant. 7. Patient must have an ECOG performance status of less than or equal to 2. 8. Patients must be able to start prophylactic antifungal therapy within 48 hours of their transplant chemotherapy preparative regimen (and prior to the initiation of cyclosporine). 9. Patients must have sufficient venous access to permit the drawing of pharmacokinetics and the monitoring of safety variables. 10. Patients must be able to swallow pills. EXCLUSION CRITERIA: 1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after study completion. 2. Sexually active men who are unwilling or unable to use barrier contraception from the time of enrollment and for 12 weeks after participation in the study. 3. Sexually active WOCBP using a prohibited contraceptive method (i.e, hormonal). 4. Women who are pregnant or breastfeeding. 5. Women with a positive pregnancy test on enrollment or prior to study drug administration. 6. Patients with moderate or severe liver disease, as defined by: AST, ALT, alkaline phosphatase, or bilirubin greater than 5 times upper limit of normal (ULN). 7. Patients with a history of anaphylaxis attributed to the azole class of antifungals. 8. Patients with a concomitant medical condition, in the opinion of the investigator and/or medical monitor, whose participation may create an unacceptable additional risk for the patient. 9. Patients receiving another non-FDA approved investigational drug up to two weeks prior to starting study drug. 10. Patient diagnosed with a deeply invasive fungal infection at time of enrollment based on the MSG/EORTC criteria. 11. Patients currently receiving other experimental antifungal therapy. (Note: All systemic antifungal therapy must be discontinued prior to enrollment). 12. Patients receiving rifampin therapy. 13. Patients receiving QTc prolonging medication such as terfenadine, cisapride, quinidine, pimozide and dofetilide.
Total Enrollment: 48
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030205; 03-C-0205
Study Start Date: May 27, 2003
Record last reviewed: May 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061555
Other Hematopoietic Stem Cell Transplantation Studies:
1. Blood and Marrow Transplant Clinical Research Network
2. Sibling Donor Cord Blood Banking and Transplantation
3. Cord Blood Stem Cell Transplantation Study (COBLT)
4. A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
5. Induction of Stable Chimerism for Sickle Cell Anemia
Related Studies:
Other Hematopoietic Stem Cell Transplantation Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Use of Ravuconazole to Prevent Fungal Infections in Bone Marrow Transplant Patients
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