Status:
TERMINATED
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Infection
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 voriconaz...
Detailed Description
OBJECTIVES: Primary * Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate. Secon...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00238355
Start Date
August 1 2003
End Date
June 1 2008
Last Update
April 27 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098