Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Neoplasm Metastasis

In brief

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Key facts

Study ID

NCT00323882

Run by

Bristol-Myers Squibb

People needed

75

Starts

2006-01-01

Expected to finish

2013-07-01

Last updated by the study team

2014-08-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of adenocarcinoma of the prostate
• Metastatic prostate cancer (positive bone scan or measurable disease)
• Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.
• Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.
• Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
• Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
• Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
• No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
• Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

You may not qualify if…

• Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.
• History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
• Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
• Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
• Active infection requiring therapy.
• Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Josephine Ford Cancer Center-Downriver — Brownstown, Michigan, United States
• Henry Ford Medical Center-Fairlane — Dearborn, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Henry Ford Medical Center-West Bloomfield — West Bloomfield, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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