MDACC Study Summary 2008-0443

Study Summary
No. 2008-0443:.......Leukemia......Jorge Cortes......Leukemia

Study Summary Title



Study Summary Number:	2008-0443

Study Title:	Kinetics of 1, 3 Beta-d- Glucan Assay in Patients with Hematologic Malignancies Receiving Voriconazole Prophylaxis

Physician

New Patient Referral



Name:	Jorge Cortes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5783 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Pfizer

Phase of Study:	Phase III	Return Visit:	not applicable

Treatment Agents:	Voriconazole	Home Care:	not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Patients will be inpatient due to chemotherapy, samples will be taken during the hospitalization


Description/ Intervention:	The goal of this clinical research study is to learn if voriconazole can cause blood tests to show that patients have a fungal infection when they actually do not. Researchers also want to learn if there is a difference in this effect when the drug is given by mouth as compared to through a needle in the vein.

Study Objectives / Outcomes

To investigate the relationship between the administration of intravenous (IV) and oral voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative to the standard assessment criteria used to diagnose invasive fungal infection in patients (pts) with hematologic malignancies.

Study Status Information



Study Activation / Registration Date:	04/02/2009

IRB Review and Approval Date:	04/02/2009

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.

2) Age >/= 18 years.

3) Patients must sign an informed consent.

Exclusion Criteria:

1) Patients with history of anaphylaxis attributed to azole compounds: voriconazole, itraconazole, fluconazole, posaconazole

2) Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (EORTC criteria).

3) Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or SGPT or SGOT > 5 times upper limit normal.

4) Patients receiving any medication that is contraindicated with the use of voriconazole. Voriconazole is contraindicated with the co-administration of the following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine, ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h), carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and efavirenz), St. John's Wort.

5) Patients currently receiving voriconazole for antifungal prophylaxis.

Links

Registration Number: NCT00904995
Study Information on Clinical Trials Registry (clinicaltrials.gov)