A Phase II Randomized, Double Blind, Placebo-controlled, Trial of Combination Antifungal Therapy (Voriconazole Plus Micafungin vs. Voriconazole Plus Placebo Equivalent) in the Treatment of Invasive Aspergillosis (IA) in Patients With Hematological Cancer

Inclusion Criteria:

1. The patient or legally authorized representative has signed an informed
consent/assent.

Assent will be obtained as required by the UAMS IRB.

2. The patient has a diagnosis of proven or probable invasive aspergillosis and with
positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving
antibiotics, such as piperacillin-tazobactam, that are known to cause false positive
GMI

3. The patient is 18 years of age or older.

Exclusion Criteria:

1. The patient is being treated with an unlicensed investigational drug for
aspergillosis.

2. The patient has been administered an antifungal agent (voriconazole, itraconazole,
posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid
formulation of amphotericin B) for > 7 days immediately prior to randomization for
treatment of the Probable, or Proven invasive aspergillosis for which the patient is
being enrolled.

3. Patient has invasive aspergillosis but with negative Aspergillus GM index.

4. The patient is pregnant or lactating. If the patient is female and of childbearing
potential, the patient must have a negative pregnancy test and avoid becoming
pregnant while receiving study drug. A pregnancy test should be performed within 14
days prior to the first dose of study drug.

5. The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five
times the upper limit of normal.

6. The patient has hepatic cirrhosis.

7. Patients with creatinine > 3 will be enrolled only if able to receive oral
voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then
oral maintenance 200 mg PO q 12 hours).

8. The patient is on artificial ventilation, and unlikely to be extubated within 24
hours of study entry.

9. The patient has a history of allergy, hypersensitivity, or any serious reaction to
the azole or echinocandin class of antifungal agents.

10. The patient has previously enrolled into this study.

11. The patient has a concomitant medical condition, which in the opinion of the
Investigator may create an unacceptable additional risk.

12. The patient has an active microbiologically-documented deep infection due to a
non-Aspergillus mold.

13. The patient has a life expectancy of less than seven days.