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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110045 |
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 | Intervention | Phase |
---|---|---|
Cancer |
Drug: caspofungin acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
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) |
Estimated Enrollment: | 149 |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of proven or probable invasive aspergillosis (IA)
Meets any of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No severe hepatic insufficiency
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Belgium | |
CHU Liege - Domaine Universitaire du Sart Tilman | Recruiting |
Liege, Belgium, B-4000 | |
Contact: Contact Person 32-4-366-7111 | |
France | |
Centre Hospitalier Universitaire Henri Mondor | Recruiting |
Creteil, France, 94010 | |
Contact: Contact Person 33-1-49-812-590 | |
Hopital Edouard Herriot - Lyon | Recruiting |
Lyon, France, 69437 | |
Contact: Contact Person 33-4-7211-7401 | |
Hopital Saint-Louis | Recruiting |
Paris, France, 75475 | |
Contact: Contact Person 33-1-4249-4949 | |
Hopital Universitaire Hautepierre | Recruiting |
Strasbourg, France, 67098 | |
Contact: Contact Person 33-388-127-682 | |
Germany | |
Medizinische Poliklinik, Universitaet Wuerzburg | Recruiting |
Wuerzburg, Germany, D-97070 | |
Contact: Contact Person Not Available | |
Italy | |
Istituto Nazionale per la Ricerca sul Cancro | Recruiting |
Genoa, Italy, 16132 | |
Contact: Claudio Viscoli, MD 39-10-555-5121 | |
Ospedale San Martino | Recruiting |
Genoa, Italy, 16132 | |
Contact: Contact Person 39-10-560-0665 | |
Ospedale Santa Croce | Recruiting |
Cuneo, Italy, 12100 | |
Contact: Contact Person 39-0171-441-309 | |
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Recruiting |
Rome, Italy, 00168 | |
Contact: Contact Person 39-06-30-15-55-56 | |
Slovakia | |
National Cancer Institute - Bratislava | Recruiting |
Bratislava, Slovakia, 833 10 | |
Contact: Contact Person 421-2-5477-2362 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, CH-1011 | |
Contact: Contact Person 41-21-314-0150 | |
Turkey | |
Hacettepe University - Faculty of Medicine | Recruiting |
Ankara, Turkey, 06100 | |
Contact: Contact Person 90-312-305-1080 |
Study Chair: | Claudio Viscoli, MD | Istituto Nazionale per la Ricerca sul Cancro |
Study ID Numbers: | CDR0000423477, EORTC-65041, EUDRACT-2004-002944-90 |
Study First Received: | May 3, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00110045 |
Health Authority: | Unspecified |
infection ataxia telangiectasia accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic 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 |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Preleukemia Leukemia, Prolymphocytic Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Myelodysplastic syndromes Essential thrombocytosis |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Caspofungin Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Hairy cell leukemia |
Anti-Infective Agents Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Therapeutic Uses Antifungal Agents Pharmacologic Actions |