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Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer
This study is currently recruiting participants.
Verified by Medarex, June 2007
Sponsored by: Medarex
Information provided by: Medarex
ClinicalTrials.gov Identifier: NCT00323882
  Purpose

This is a multicenter study in which up to 34 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. A total of 16 patients will be enrolled at the maximum tolerated dosage level. Patients will be followed for 1 year or until disease progression. 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 I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Ipilimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Medarex:

Primary Outcome Measures:
  • The primary objectives of the study are to determine the safety profile
  • maximum tolerated dose (MTD)
  • and dose-limiting toxicity (DLT) of escalating doses of MDX-010 administered every 3 weeks up to 4 times to patients with HRPC.

Secondary Outcome Measures:
  • The secondary objective is to provide a preliminary assessment of clinical antitumor activity, including an assessment of prostate-specific antigen (PSA) responses and metabolic bone activity.

Estimated Enrollment: 34
Study Start Date: February 2005
Detailed Description:

This is a multicenter Phase I/II, open-label, dose-escalation study. Up to 34 chemotherapy- and immunotherapy-naive patients with metastatic hormone refractory prostate cancer will be administered intravenous (iv) infusions of MDX-010 every 3 weeks for 4 doses at escalating dosage levels of 3, 5, 7.5, and 10 mg/kg/dose. At least 6 patients will be enrolled at each dose level. Upon establishment of a maximum tolerated dose (MTD), additional patients, to accrue a total of 16 patients at the MTD dose level, will be enrolled to collect additional data for safety, tolerability, pharmacokinetics, and activity.

The duration of treatment for patients is 12 weeks; MDX-010 will be administered on Days 1, 22, 43, and 64. Evaluations to assess clinical response will be performed on Day 85. Patients will then be followed for approximately 1 year or until disease progression. The study duration for each individual patient is up to 16 months. Patients who tolerate or respond to initial therapy with MDX-010 or who have stable disease of 3 months or greater and who subsequently progress during the follow up phase will have the option to enroll in an extension protocol to receive additional cycles of MDX-010 therapy.

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent form
  • 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 (specified below), and then observe disease progression. Flutamide must be discontinued at least 4 weeks before beginning screening. Bicalutamide (Casodex), nilutamide, aminoglutethimide, ketoconazole, diethylstilbestrol, megestrol acetate (Megace), and Proscar (finasteride) must be discontinued at least 6 weeks before beginning screening.
  • 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.
  • Life expectancy of 12 weeks or greater.
  • ECOG performance status of 0 or 1.
  • Patients who are sexually active with a partner who could become pregnant are to use an effective form of barrier contraception.
  • Must meet screening laboratory values.

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.
  • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for 5 years or greater.
  • 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, and positive HIV-1, HIV-2, human T-cell leukemia virus type 1 (HTLV-1), hepatitis B surface antigen, or hepatitis C positive RNA.
  • Underlying medical condition that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
  • 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.
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323882

Contacts
Contact: Andrea Kelly 908-479-2505 akelly@medarex.com
Contact: Katelyn Powers 908-479-2642 kpowers@medarex.com

Locations
United States, California
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Tanya B Dorff, MD            
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Eric J. Small, MD            
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 11818
Principal Investigator: Omid Hamid, M.D.            
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Andrea Harzstark, MD            
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Wm K Kelly, DO            
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202-2689
Principal Investigator: Sheela Tejwani, MD            
Henry Ford Medical Center-Fairlane Recruiting
Dearborn, Michigan, United States, 48126
Principal Investigator: Sheela Tejwani, MD            
Henry Ford Medical Center-West Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Principal Investigator: Sheela Tejwani, MD            
Josephine Ford Cancer Center-Downriver Recruiting
Brownstown, Michigan, United States, 48183
Principal Investigator: Sheela Tejwani, MD            
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Joel Picus, MD            
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Principal Investigator: Susan F Slovin, MD, PhD            
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Principal Investigator: John D Powderly, II, MD            
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Principal Investigator: Tomasz M Beer, MD            
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Celestia Higano, MD            
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Celestia Higano, MD            
Sponsors and Collaborators
Medarex
Investigators
Study Director: Israel Lowy, MD Medarex
  More Information

Study ID Numbers: MDX010-21
Study First Received: May 8, 2006
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00323882  
Health Authority: United States: Food and Drug Administration

Keywords provided by Medarex:
Prostate Cancer
Oncology
Prostate
Cancer
Metastatic
Hormone
PSA
Metastatic Hormone-Refractory Prostate Cancer (HRPC)

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009