Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Condition: Infection; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: caspofungin acetate; voriconazole
Intervention description: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84.; 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).
Intervention MeSH terms: Voriconazole; Caspofungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infection; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in
      patients who have weakened immune systems.

      PURPOSE: This phase II trial is studying how well giving voriconazole together with
      caspofungin acetate works in treating invasive fungal infections in patients with weakened
      immune systems.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of probable or definite invasive fungal infection with 1 of the following
             organisms:

               -  Aspergillus species

               -  Fusarium species

               -  Scedosporium species (Pseudallescheria boydii)

               -  Other dematiaceous molds

          -  The following diagnosis are not allowed:

               -  Zygomycetes (Mucor or Rhizopus species)

               -  Chronic aspergillosis

               -  Aspergilloma

               -  Allergic bronchopulmonary aspergillosis

          -  Must be immunocompromised

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Not specified

        Life expectancy

          -  At least 72 hours

        Hematopoietic

          -  Not specified

        Hepatic

          -  AST < 5 times upper limit of normal (ULN)

          -  Bilirubin < 5 times ULN

          -  Alkaline phosphatase < 5 times ULN

          -  No Child-Pugh class C cirrhosis

        Renal

          -  Creatinine clearance ≥ 50 mL/min

        Pulmonary

          -  No mechanical ventilation

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No hypersensitivity to azoles, caspofungin acetate, or their components

          -  No history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
             malabsorption

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  More than 14 days since prior therapeutic antifungal therapy of ≥ 1 week duration

          -  More than 14 days since prior and no concurrent administration of any of the following
             medications:

               -  Terfenadine

               -  Astemizole

               -  Cisapride

               -  Pimozide

               -  Quinidine

               -  Sirolimus

               -  Rifampin

               -  Carbamazepine

               -  Long-acting barbiturates

               -  Rifabutin

               -  Ergot alkaloids (i.e., ergotamine and dihydroergotamine)