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A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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.

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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed Prostate-Specific Antigen (PSA) Response

Outcome Description:

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.

Outcome Time Frame:

Assessed every 3 cycles (1 cycle = 14 days) until progression

Safety Issue:

No

Principal Investigator

Jacek Pinski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000526555

NCT ID:

NCT00433446

Start Date:

April 2007

Completion Date:

July 2011

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
University of California Davis Cancer CenterSacramento, California  95817
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
California Pacific Medical Center - California CampusSan Francisco, California  94118
Sutter Solano Medical CenterVallejo, California  94589
Poudre Valley HospitalFort Collins, Colorado  80524
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Mecosta County Medical CenterBig Rapids, Michigan  49307
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Adventist Medical CenterPortland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California  91204
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
AnMed Cancer CenterAnderson, South Carolina  29621
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
Regional Medical CenterAnniston, Alabama  36202
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115