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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00433446
First received: February 8, 2007
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Biological: CNTO 328
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Confirmed Prostate-Specific Antigen (PSA) Response [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ] [ Designated as safety issue: No ]
    PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.

  • Overall Survival (OS) [ Time Frame: 0-3 yeas after registration ] [ Designated as safety issue: No ]
    Measured from date of registration to date of death due to any cause or last contact

  • Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease [ Time Frame: Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression ] [ Designated as safety issue: No ]
    Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

  • Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.


Enrollment: 62
Study Start Date: April 2007
Study Completion Date: July 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNTO 328 Biological: CNTO 328
Other Name: anti-IL-6 chimeric monoclonal antibody

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  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: NCT00433446

  Hide Study Locations
Locations
United States, Alabama
Regional Medical Center
Anniston, Alabama, United States, 36202
United States, Arkansas
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Peninsula Medical Center
Burlingame, California, United States, 94010
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States, 94904
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States, 94904
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
University of California Davis Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Colorado
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Florida
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
United States, Illinois
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Iowa
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Metro Health Hospital
Grand Rapids, Michigan, United States, 49506
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Holland Community Hospital
Holland, Michigan, United States, 49423
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Mount Clemens, Michigan, United States, 48043
Hackley Hospital
Muskegon, Michigan, United States, 49442
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Community Medical Center
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New York
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Adventist Medical Center
Portland, Oregon, United States, 97216
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States, 24115
United States, Washington
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Group Health Central Hospital
Seattle, Washington, United States, 98112
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Jacek Pinski, MD University of Southern California
  More Information

Additional Information:
Publications:
Pinski JK, Goldman B, Dorff T, et al.: SWOG S0354: A phase II trial of CNTO328, a monoclonal antibody against interleukin-6 (IL-6), in chemotherapy pretreated patients (pts) with castration- resistant prostate cancer (CRPC). [Abstract] J Clin Oncol 27 (Suppl 15): A-5143, 2009.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00433446     History of Changes
Other Study ID Numbers: CDR0000526555, U10CA032102, S0354
Study First Received: February 8, 2007
Results First Received: November 9, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014