Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer (MDX010-21)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00323882
First received: May 8, 2006
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, will receive MDX-010 every 3 weeks for 4 doses (12 weeks total duration). MDX-010 will be administered at escalating dosage levels of 3, 5, 7.5 and 10 mg/kg/dose infusions. At least 6 patients will be enrolled in each dosage level. Patients will be followed for 1 year or until disease progression to assess response. Patients will be followed for survival status for up to 7 years after enrollment. Patients who tolerate and respond to treatment or who have stable disease for 3 months or longer and who subsequently progress during the follow up phase of the study may have the option to receive additional treatment with MDX-010.


Condition Intervention Phase
Prostate Cancer
Neoplasm Metastasis
Drug: MDX-010
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary objective of the study is to determine the safety profile [ Time Frame: varied timepoints ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Provide a preliminary assessment of clinical antitumor activity, including an assessment of prostate-specific antigen (PSA) responses and metabolic bone activity. [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
  • Determine whether additional dosing in patients with mixed response or stable disease can elicit an objective response [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: February 2005
Study Completion Date: July 2013
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDX-010 Drug: MDX-010
selected dose administered IV every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of adenocarcinoma of the prostate
  • Metastatic prostate cancer (positive bone scan or measurable disease)
  • Total testosterone of greater 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323882

Locations
United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 11818
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Michigan
Josephine Ford Cancer Center-Downriver
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689
Henry Ford Medical Center-West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00323882     History of Changes
Other Study ID Numbers: MDX010-21, CA184-017
Study First Received: May 8, 2006
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Prostate Cancer
Oncology
Prostate
Cancer
Metastatic
Hormone
PSA
Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014