Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00623766
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance
  • Corticosteroid: Betamethasone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone
  • Corticosteroid: Dexamethasone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with dexamethasone
  • Corticosteroid: Fludrocortisone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with fludrocortisone
  • Corticosteroid: Hydrocortisone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with hydrocortisone
  • Corticosteroid: Meprednisone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with meprednisone
  • Corticosteroid: Methylprednisolone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with methylprednisolone
  • Corticosteroid: Prednisolone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisolone
  • Corticosteroid: Prednisone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisone
  • Corticosteroid: Triamcinolone — DRUG
    Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with triamcinolone

Study Details

To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.

Key Dates

Start date
Jul 31, 2008
Status verified
May 2014
Primary completion
Sep 30, 2009
Completion
Oct 31, 2012

Study Design

Enrollment
99 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab, 10 mg/kg, IV in corticosteroid-free patients
    Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.
  • Experimental: Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients
    Participants who were dependent on corticosteroid therapy received ipilimumab, 10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.

Primary Outcome Measure

Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria [ Time Frame: From Day 1, first dose to end of Week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
City Of HopeDuarteCalifornia91010-3000-
The Angeles Clinic & Research InstituteLos AngelesCalifornia90025-
Yale University School Of MedicineNew HavenConnecticut06520-
Loyola University Medical CenterMaywoodIllinois60153-
Oncology Specialists, S.C.Park RidgeIllinois60068-
Indiana University Cancer CenterIndianapolisIndiana46202-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Local InstitutionThe BronxNew York10466-
Providence Portland Med CtrPortlandOregon97213-
Vanderbilt-Ingram Cancer CtrNashvilleTennessee37232-
Seattle Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Mayo Clinic Arizona· Scottsdale, AZCity Of Hope· Duarte, CAThe Angeles Clinic & Research Institute· Los Angeles, CAYale University School Of Medicine· New Haven, CTLoyola University Medical Center· Maywood, ILOncology Specialists, S.C.· Park Ridge, IL

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