A Multicenter, Open, Phase II Study to Estimate the Activity and Safety of Caspofungin (CASP) in the First-Line Treatment of Probable and Proven Invasive Aspergillosis (IA) in Patients With Hematological Malignancies (HM) or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
- 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
- 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.
Masking: Open Label, Primary Purpose: Supportive Care
Response rate as assessed by standard criteria after completion of study treatment
Claudio Viscoli, MD
National Institute for Cancer Research, Italy
United States: Federal Government