RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

Condition	Treatment or Intervention	Phase
Cancer Infection	Drug: caspofungin acetate  Procedure: antifungal therapy  Procedure: complications of therapy assessment/management  Procedure: infection prophylaxis/management  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the activity of caspofungin acetate as first-line therapy for proven or probable invasive aspergillosis, in terms of response rate, in patients with hematologic malignancies or in patients who have undergone hematopoietic stem cell transplantation.

Secondary

• Determine the 84-day response rate in patients treated with this drug.
• Determine the 84-day survival rate in patients treated with this drug.
• Determine the safety of this drug, in terms of the rate of overall drug-related adverse events, the rate of overall drug-related serious adverse events, and the rate of drug-related adverse events leading to treatment discontinuation, in these patients.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease and/or type of prior hematopoietic stem cell transplantation (HSCT) (hematologic malignancy or autologous HSCT vs allogeneic HSCT).

Patients receive caspofungin acetate IV over approximately 1 hour once daily on days 1-15 in the absence of disease progression or unacceptable toxicity.

Patients achieving a complete response (CR) or partial response (PR) after day 15 may continue to receive caspofungin acetate as above until day 84 OR discontinue study treatment after day 15 and shift to an oral antifungal drug for maintenance therapy or prophylaxis, if considered to be in the best interest of the patient. Patients achieving stable disease after day 15 continue to receive caspofungin acetate as above until day 28. These patients then undergo a second evaluation. Patients who maintain stable disease continue to receive caspofungin acetate as above until day 84. Patients achieving CR or PR are treated as per CR or PR treatment described above.

After completion of study treatment, patients are followed weekly for 30 days.

PROJECTED ACCRUAL: A total of 149 patients (87 in stratum 1, 62 in stratum 2) will be accrued for this study within 18 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of proven or probable invasive aspergillosis (IA)
• Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and aspergillus galactomannan evaluation within 7 days after study entry
• Meets any of the following criteria:
• Diagnosis of a hematologic malignancy
• Underwent autologous or allogeneic hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 20-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST and ALT ≤ 5 times upper limit of normal (ULN)
• Bilirubin ≤ 5 times ULN
• Alkaline phosphatase ≤ 5 times ULN
• No severe hepatic insufficiency
• Child-Pugh score ≤ 9

Renal

• No severe renal failure requiring hemodialysis or peritoneal dialysis
• Creatinine < 3.4 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception
• No known HIV positivity
• No history of allergy or adverse reaction to echinocandin drugs
• No known bacterial infection that is not adequately treated
• No psychological, familial, social, or geographical condition that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours
• Prior prophylactic oral antifungals allowed
• Prior prophylactic IV fluconazole allowed
• More than 14 days since prior and no concurrent investigational agents
• No prior participation in this study
• No prior echinocandins
• No other concurrent antifungal therapy

Please refer to this study by ClinicalTrials.gov identifier  NCT00110045

Italy
      Istituto Nazionale per la Ricerca sul Cancro, Genoa,  16132,  Italy; Recruiting

Study chairs or principal investigators

Claudio Viscoli, MD,  Study Chair,  Istituto Nazionale per la Ricerca sul Cancro   

Study ID Numbers:  CDR0000423477; EORTC-650451; EUDRACT-2004-002944-90
Record last reviewed:  April 2005
Last Updated:  May 3, 2005
Record first received:  May 3, 2005
ClinicalTrials.gov Identifier:  NCT00110045
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17