Spots Global Cancer Trial Database for Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
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Trial Identification
Brief Title: Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
Official Title: An Open-Label, Dose Finding, Prospective, Multi Center, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Three Different Dose Levels of AVI 014 (G-CSF) Compared With a Standard Dose of Neupogen® in Breast Cancer Patients at High (>20%) Risk for Chemotherapy Induced Severe Neutropenia
Study ID: NCT00497809
Interventions
Study Description
Brief Summary: The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor \[G-CSF\]) in breast cancer patients at high (\>20%) risk for chemotherapy-induced severe neutropenia.
Detailed Description: Filgrastim is a recombinant human G-CSF (rhG-CSF) developed in the mid 1980s, and was approved by the United States (US) Food and Drug Administration (FDA) for use in chemotherapy induced neutropenia in 1991 under the trade name Neupogen®. Filgrastim was first approved in the EU in Germany in 2001 under the same trade name. Filgrastim is a non glycosylated protein, produced in E. coli bacteria transfected with rhG-CSF copy deoxyribonucleic acid (cDNA). Filgrastim differs from native human G CSF only in the addition of an N terminal methionine required for expression in a bacterial host. In 2002, a pegylated filgrastim with extended duration of action relative to the naked filgrastim was approved by the FDA and the EU Commission under the trade name Neulasta. AviGenics has generated transgenic hens carrying rhG CSF cDNA, which express a glycosylated form of rhG-CSF protein in their egg white. The purified rhG-CSF is biologically active, as assessed by its in vitro binding and cell proliferation activities, and has been fully characterized by AviGenics. AviGenics intends to develop this product to treat chemotherapy-induced neutropenia. The overall goal of this study is to assess dose response, efficacy, and safety of three different dose levels of AVI-014 (G-CSF) in breast cancer patients at high (\>20%) risk for chemotherapy induced severe neutropenia.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Anaheim, California, United States
California Cancer Center, Greenbrae, California, United States
Ghassan Al-Jazayrly, MD, Inc., Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
Brian LeBerthon, MD, A Medical Corporation, West Covina, California, United States
Infosphere Clinical Research, West Hills, California, United States
Physicians Research Alliance LLC., Debary, Florida, United States
Southern Illinois Hematology/Oncology, Centralia, Illinois, United States
Gabrail Cancer Center, Canton, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
University of Oklahoma Health Sciences Ctr, Oklaoma City, Oklahoma, United States
Cancer Care Institute of Carolina, Aiken, South Carolina, United States
Cancer Specialists of South Texas, Corpus Christi, Texas, United States
Cancer Outreach Associates PC, Abingdon, Virginia, United States
Jawaharlal Nehru Cancer Hospital and Research Centre, Idgah Hills, Bhopal, India
Apollo Specialty Hospital, Padma Complex, 320 Mount Road, Chennai, India
Amrita Institute of Medical Sciences, Amrita Lane Elamakkara, Cochin, India
Dharamshila Hospital and research Centre, Vasundhara Enclave, Delhi, India
Apollo Hospitals Educational and Research Foundation, Jubilee hills, Hyderabad, India
Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road, Bangalore, Karnataka, India
Mohan Dai Oswal Cancer Treatment & Research Foundation, G.T. Road, Sherpur Bye Pass, Ludhiana, India
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana, India
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai,, India
Kasturba Medical College Hospital, Attavar, Mangalore, India
Tata Memorial Hospital,, Dr. E Borges Road, Parel, Mumbai, India
Indraprastha Apollo Hospital, Delhi Mathura road, Sarita vihar, New Delhi, India
Dharamshila Cancer Center, Dharamshila Marg, Vasundhara Enclave, New Delhi, India
Regional Cancer Centre, IGIMS, Sheikhpura, Patna, India
Ruby Hall Clinic, 40 Sasoon Road, Pune, India
King George Hospital, Vizag, Vishakhapattanam, India
IRCH, AIIMS, Ansari Nagar,, New Delhi, , India
Contact Details
Name: Howard Ozer, MD
Affiliation: University of Oklahoma
Role: PRINCIPAL_INVESTIGATOR
Name: Robert J. Grieve, M.B,Ch.B., FRCR
Affiliation: University Hospitals of Coventry and Warwickshire
Role: PRINCIPAL_INVESTIGATOR
Name: Walter Kraft, MD, MS, FACP
Affiliation: AviGenics
Role: STUDY_CHAIR
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