Study of Ipilimumab to Treat Melanoma in Patients With Brain Metastases - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00623766

Purpose

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

Condition	Intervention	Phase
Melanoma	Drug: Ipilimumab Drug: Steroids	Phase II

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:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

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 ]

Estimated Enrollment:	72
Study Start Date:	July 2008
Estimated Study Completion Date:	April 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 + Steroids	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: Steroids Oral, tablets, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response

Eligibility

Criteria

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
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
Ucsf Mount Zion
San Francisco, California, United States, 94143
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, 02115
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
North Division Montefiore
Bronx, New York, United States, 10466
Mem Sloan-Ket Can Ctr
New York, New York, United States, 10021
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

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00623766 History of Changes
Other Study ID Numbers:	CA184-042
Study First Received:	February 19, 2008
Last Updated:	February 2, 2012
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 February 09, 2012