Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00289640
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab (MDX-010, BMS-734016) — DRUG
    IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
  • Ipilimumab — DRUG
    IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
  • Ipilimumab — DRUG
    IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

Study Details

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

Key Dates

Start date
Apr 30, 2006
Status verified
Jan 2009
Primary completion
Jul 31, 2007
Completion
Jul 31, 2007

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2
  • Experimental: 3

Primary Outcome Measure

estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.

Locations (25)

FacilityCityStateZIPSite coordinators
Arizona Cancer CenterTucsonArizona85724-
Wilshire Oncology Medical Group IncLaverneCalifornia91750-
Scripps Cancer CenterSan DiegoCalifornia92121-
The Angeles Clinic And Research InstitutionSanta MonicaCalifornia90404-
Yale University School Of MedicineNew HavenConnecticut06520-
Baptist Cancer InstituteJacksonvilleFlorida32207-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Md Anderson Cancer Center OrlandoOrlandoFlorida32806-
Palm Beach Cancer InstituteWest Palm BeachFlorida33401-
Oncology Specialists, ScPark RidgeIllinois60068-
American Health NetworkIndianapolisIndiana46202-
University Of LouisvilleLouisvilleKentucky40202-
Harry And Jeanette Weinberg Cancer Inst At Franklin SquareBaltimoreMaryland21237-
Hubert H. Humphrey Cancer CenterRobbinsdaleMinnesota55422-
Ellis Fischel Cancer CenterColumbiaMissouri65203-
St Joseph Oncology IncSaint JosephMissouri64507-
Washington University School Of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Presbyterian HospitalCharlotteNorth Carolina28204-
The Christ Hospital Cancer Center ResearchCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
Cancer Centers Of The CarolinasGreenvilleSouth Carolina29615-
Center For Oncology Research & Treatment, P.A.DallasTexas75230-
Mary Crowley Medical Research CenterDallasTexas75246-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Arizona Cancer Center· Tucson, AZWilshire Oncology Medical Group Inc· Laverne, CAScripps Cancer Center· San Diego, CAThe Angeles Clinic And Research Institution· Santa Monica, CAYale University School Of Medicine· New Haven, CTBaptist Cancer Institute· Jacksonville, FL

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