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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Neoplasm Metastasis

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to determine the safety profile

Outcome Time Frame:

varied timepoints

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX010-21

NCT ID:

NCT00323882

Start Date:

February 2005

Completion Date:

August 2015

Related Keywords:

  • Prostate Cancer
  • Neoplasm Metastasis
  • Prostate Cancer
  • Oncology
  • Prostate
  • Cancer
  • Metastatic
  • Hormone
  • PSA
  • Metastatic Hormone-Refractory Prostate Cancer (HRPC)
  • Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Henry Ford HospitalDetroit, Michigan  48202
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Seattle Cancer Care AllianceSeattle, Washington  98109
Oregon Health and Science UniversityPortland, Oregon  97201
Yale University School Of MedicineNew Haven, Connecticut  06520
Carolina BioOncology InstituteHuntersville, North Carolina  28078
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Josephine Ford Cancer Center-DownriverBrownstown, Michigan  48183
Henry Ford Medical Center-FairlaneDearborn, Michigan  48126
Henry Ford Medical Center-West BloomfieldWest Bloomfield, Michigan  48322