Prostate Cancer Clinical Trial
Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 14 Locations for this study
Los Angeles California, 11818, United States
Los Angeles California, 90025, United States
San Francisco California, 94115, United States
New Haven Connecticut, 06520, United States
Brownstown Michigan, 48183, United States
Dearborn Michigan, 48126, United States
Detroit Michigan, 48202, United States
West Bloomfield Michigan, 48322, United States
St. Louis Missouri, 63110, United States
New York New York, 10021, United States
Huntersville North Carolina, 28078, United States
Portland Oregon, 97239, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
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