A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
Primary
- Assess the confirmed prostate-specific antigen response in patients with
hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric
monoclonal antibody.
Secondary
- Assess overall survival and progression-free survival of these patients.
- Assess the objective response rate (confirmed and unconfirmed, complete and partial
response) in patients with measurable disease treated with this regimen.
- Assess the qualitative and quantitative toxicities of this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive anti-IL-6 chimeric monoclonal antibody IV over 2 hours on day 1. Treatment
repeats every 2 weeks for up to 12 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed Prostate-Specific Antigen (PSA) Response
PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.
Assessed every 3 cycles (1 cycle = 14 days) until progression
No
Jacek Pinski, MD
Study Chair
USC/Norris Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000526555
NCT00433446
April 2007
July 2011
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Southwest Medical Center | Liberal, Kansas 67901 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Pennington Cancer Center at Baton Rouge General | Baton Rouge, Louisiana 70806 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
University Hospital - San Antonio | San Antonio, Texas 78229 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Adventist Medical Center | Portland, Oregon 97216 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
Regional Medical Center | Anniston, Alabama 36202 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |