Trial record 9 of 10 for:    "ataxia-telangiectasia"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00110045
First received: May 3, 2005
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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

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

Enrollment: 171
Study Start Date: February 2005
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110045

Locations
Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
France
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
Germany
Medizinische Poliklinik, Universitaet Wuerzburg
Wuerzburg, Germany, D-97070
Italy
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
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Turkey
Hacettepe University - Faculty of Medicine
Ankara, Turkey, 06100
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Claudio Viscoli, MD National Institute for Cancer Research, Italy
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00110045     History of Changes
Other Study ID Numbers: EORTC-65041, EORTC-65041, EUDRACT-2004-002944-90
Study First Received: May 3, 2005
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
ataxia-telangiectasia
infection
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:
Aspergillosis
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Mycoses
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014