Study of Ipilimumab to Treat Melanoma in Patients With Brain Metastases

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00623766
First received: February 19, 2008
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

To determine if melanoma brain metastases will respond to ipilimumab treatment while being generally well tolerated


Condition Intervention Phase
Melanoma
Drug: Ipilimumab
Drug: Corticosteroid with Investigator choice
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 Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Tumor assessment [ Time Frame: after 12 weeks of first dose and then every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival - Incidence of MRI defined brain edema [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of treatment [ Time Frame: Every study visit ] [ Designated as safety issue: Yes ]
  • Response of tumor in presence or absence of corticosteroids [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: July 2008
Study Completion Date: October 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Other Names:
  • BMS-734016
  • MDX-010
Experimental: Ipilimumab + Corticosteroid with Investigator choice Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Other Names:
  • BMS-734016
  • MDX-010
Drug: Corticosteroid with Investigator choice
Oral, tablets, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

  • Malignant melanoma with measurable brain metastases
  • At least one measurable index metastatic brain lesion, with its greatest dimension > 0.5 cm and no larger than 3 cm in diameter, that has not been previously irradiated, and/or at least 2 measurable lesions > 0.3 cm that are visible on contrast-enhanced MRI
  • ECOG 0-1
  • Stable labs
  • Age >/= 16 years

Exclusion

  • Auto immune disease, Hepatitis or HIV, other cancer
  • Previous treatment with other CTLA-4 agonists, or concurrent IL-2 therapy
  • Major surgery within 28 days
  • Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623766

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
City Of Hope
Duarte, California, United States, 91010-3000
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Local Institution
Bronx, New York, United States, 10466
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Providence Portland Med Ctr
Portland, Oregon, United States, 97213
United States, Tennessee
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
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: NCT00623766     History of Changes
Other Study ID Numbers: CA184-042
Study First Received: February 19, 2008
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014