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Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110045
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Cancer Drug: caspofungin acetate Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Masking: None (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)
Study Start Date : February 2005
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
Genetic and Rare Diseases Information Center resources: Lymphosarcoma Mycosis Fungoides Cutaneous T-cell Lymphoma Anaplastic Large Cell Lymphoma Multiple Myeloma Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myelodysplastic/myeloproliferative Disease Chronic Lymphocytic Leukemia Myeloid Leukemia Myelodysplastic Syndromes Chronic Myeloproliferative Disorders Ovarian Cancer Ovarian Epithelial Cancer Chronic Myeloid Leukemia Polycythemia Vera Follicular Lymphoma B-cell Lymphoma Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Acute Non Lymphoblastic Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Gestational Trophoblastic Tumor Neuroblastoma AL Amyloidosis Aspergillosis Hodgkin Lymphoma Marginal Zone Lymphoma Primary Myelofibrosis Essential Thrombocythemia Burkitt Lymphoma Monoclonal Gammopathy of Undetermined Significance Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Hairy Cell Leukemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma Ataxia Telangiectasia Post-transplant Lymphoproliferative Disease Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia Lymphomatoid Granulomatosis T-cell Large Granular Lymphocyte Leukemia

Primary Outcome Measures :
  1. Response rate as assessed by standard criteria after completion of study treatment

Secondary Outcome Measures :
  1. Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment
  2. Survival rate at 84 days
  3. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 20-100%

Life expectancy

  • Not specified


  • Not specified


  • 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


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


  • 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


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110045

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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
Hopital Saint-Louis
Paris, France, 75475
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
Medizinische Poliklinik, Universitaet Wuerzburg
Wuerzburg, Germany, D-97070
Ospedale Santa Croce
Cuneo, Italy, 12100
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale San Martino
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Claudio Viscoli, MD IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00110045    
Other Study ID Numbers: EORTC-65041
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic neutrophilic leukemia
essential thrombocythemia
polycythemia vera
adult acute lymphoblastic leukemia in remission
recurrent adult acute lymphoblastic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia in remission
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action