S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

NCT ID: NCT00433446

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-07-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CNTO 328

Group Type: EXPERIMENTAL

CNTO 328

Intervention Type: BIOLOGICAL

Interventions

CNTO 328

Intervention Type: BIOLOGICAL

Other Intervention Names

anti-IL-6 chimeric monoclonal antibody

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Metastatic disease (N1 and/or M1)
• Disease unresponsive or refractory to androgen-deprivation therapy
• Must have received only 1 prior chemotherapy regimen comprising a taxane OR mitoxantrone
• Disease progression as defined by one or more of the following:

• Progression of measurable disease

• Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months ago and lesion progressed since radiotherapy
• Progression of nonmeasurable disease

• Prior radiotherapy within the past 2 months allowed, but disease is considered nonmeasurable
• Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR within 6 months of last chemotherapy dose

• Rising PSA defined as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1)
• PSA ≥ 5 ng/mL
• Surgical or medical castration required

• Castration using luteinizing hormone-releasing hormone agonist (leuprolide acetate or goserelin) or antagonist (abarelix) should not be interrupted
• No history of brain metastases OR currently treated or untreated brain metastases

• Patients with clinical suspicion of brain metastases must have a brain CT scan or MRI negative for metastatic disease within the past 56 days

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• Fertile patients must use effective contraception
• Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Hemoglobin ≥ 9 g/dL (transfusion independent)
• Creatinine clearance ≥ 40 mL/min
• Bilirubin ≤ 2 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2 times ULN
• No uncontrolled intercurrent illnesses including, but not limited to, the following:

• Diabetes mellitus
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• No psychiatric illness or social situation that would preclude study compliance
• No known HIV positivity
• No other prior malignancy except for the following:

• Adequately treated basal cell or squamous cell skin cancer
• Adequately treated stage I or II cancer in complete remission
• Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 21 days since prior surgery and recovered
• At least 28 days since prior chemotherapy and recovered
• At least 28 days since prior flutamide or ketoconazole
• At least 28 days since prior radiotherapy (to < 30% of the bone marrow only) and recovered

• Prior samarium Sm 153 lexidronam pentasodium allowed
• No prior strontium chloride Sr 89
• At least 42 days since prior bicalutamide or nilutamide
• More than 60 days since prior murine or chimeric proteins or human/murine monoclonal antibody
• Concurrent bisphosphonate therapy allowed provided the following are true:

• Therapy commenced at least 3 weeks ago
• Therapy continues for the entire duration of study treatment
• No other concurrent anticancer therapy, including cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy (except for luteinizing hormone-releasing hormone agonist or antagonist in patients who have not had an orchiectomy)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Pinski, MD

Role: STUDY_CHAIR

University of Southern California

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

Countries

United States

References

Dorff TB, Goldman B, Pinski JK, Mack PC, Lara PN Jr, Van Veldhuizen PJ Jr, Quinn DI, Vogelzang NJ, Thompson IM Jr, Hussain MH. Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with castration-resistant prostate cancer. Clin Cancer Res. 2010 Jun 1;16(11):3028-34. doi: 10.1158/1078-0432.CCR-09-3122. Epub 2010 May 18.

Reference Type: RESULT

PMID: 20484019 (View on PubMed)

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0354

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000526555

Identifier Type: -

Identifier Source: org_study_id