Spots Global Cancer Trial Database for S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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Trial Identification
Brief Title: S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer
Study ID: NCT00433446
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Regional Medical Center, Anniston, Alabama, United States
Highlands Oncology Group - Springdale, Springdale, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center, Berkeley, California, United States
Peninsula Medical Center, Burlingame, California, United States
Glendale Memorial Hospital Comprehensive Cancer Center, Glendale, California, United States
Marin Cancer Institute at Marin General Hospital, Greenbrae, California, United States
Sutter Health - Western Division Cancer Research Group, Greenbrae, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
California Pacific Medical Center - California Campus, San Francisco, California, United States
Sutter Solano Medical Center, Vallejo, California, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
M.D. Anderson Cancer Center at Orlando, Orlando, Florida, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Pennington Cancer Center at Baton Rouge General, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Metro Health Hospital, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital, Mount Clemens, Michigan, United States
Hackley Hospital, Muskegon, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Healthcare Cancer Care, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Tucker Center for Cancer Care at Orange Regional Medical Center, Middletown, New York, United States
Interlakes Oncology/Hematology PC, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Adventist Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
AnMed Cancer Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
University Hospital - San Antonio, San Antonio, Texas, United States
Danville Regional Medical Center, Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Columbia Basin Hematology, Kennewick, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Polyclinic First Hill, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Jacek Pinski, MD
Affiliation: University of Southern California
Role: STUDY_CHAIR
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