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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00433446 |
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 |
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Prostate Cancer |
Drug: anti-IL-6 chimeric monoclonal antibody |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Disease progression as defined by one or more of the following:
Progression of measurable disease
Progression of nonmeasurable disease
Rising prostate-specific antigen (PSA) after > 2 courses of chemotherapy OR within 6 months of last chemotherapy dose
Surgical or medical castration required
No history of brain metastases OR currently treated or untreated brain metastases
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illnesses including, but not limited to, the following:
No other prior malignancy except for the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior radiotherapy (to < 30% of the bone marrow only) and recovered
Concurrent bisphosphonate therapy allowed provided the following are true:
Study Chair: | Jacek Pinski, MD | Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000526555, SWOG-S0354 |
Study First Received: | February 8, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00433446 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Antibodies, Monoclonal Antibodies Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence Immunoglobulins |
Neoplasms Neoplasms by Site Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |