Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
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.
|Study Design:||Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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)|
- Response rate as assessed by standard criteria after completion of study treatment
- Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment
- Survival rate at 84 days
|Study Start Date:||February 2005|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|CHU Liege - Domaine Universitaire du Sart Tilman|
|Liege, Belgium, B-4000|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Hopital Edouard Herriot - Lyon|
|Lyon, France, 69437|
|Paris, France, 75475|
|Hopital Universitaire Hautepierre|
|Strasbourg, France, 67098|
|Medizinische Poliklinik, Universitaet Wuerzburg|
|Wuerzburg, Germany, D-97070|
|Ospedale Santa Croce|
|Cuneo, Italy, 12100|
|Ospedale San Martino|
|Genoa, Italy, 16132|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore|
|Rome, Italy, 00168|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 833 10|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Hacettepe University - Faculty of Medicine|
|Ankara, Turkey, 06100|
|Study Chair:||Claudio Viscoli, MD||National Institute for Cancer Research, Italy|