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Completed

NCT Number: NCT00110045

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.

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Key information

Conditions

Cancer Adnexal Diseases Amyloidosis Ataxia Ataxia Telangiectasia Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Brain Diseases Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma, Ovarian Epithelial Cardiovascular Diseases Cell Transformation, Neoplastic Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders DNA Virus Infections Disease Attributes Dyskinesias Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Nervous System Diseases Neuroblastoma Neurocutaneous Syndromes Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neurologic Manifestations Nutritional and Metabolic Diseases Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Immunodeficiency Diseases Primary Myelofibrosis Proteostasis Deficiencies Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Spinocerebellar Ataxias Telangiectasis Testicular Diseases Testicular Neoplasms Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Liege - Domaine Universitaire du Sart Tilman, Liège, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caspofungin acetate

Drug

Primary outcomes

  1. Response rate as assessed by standard criteria after completion of study treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
First posted
May 4, 2005
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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