S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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|
- Confirmed Prostate-Specific Antigen (PSA) Response [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ]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.
- Progression-free Survival (PFS) [ Time Frame: Assessed every 3 cycles (1 cycle = 14 days) until progression ]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 ]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 ]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 ]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.
|Study Start Date:||April 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
|Experimental: CNTO 328||
Biological: CNTO 328
Other Name: anti-IL-6 chimeric monoclonal antibody
- Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433446
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|Study Chair:||Jacek Pinski, MD||University of Southern California|