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

Sponsors and Collaborators:	Bristol-Myers Squibb Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00623766

Purpose

The purpose of this study is to determine if melanoma brain metastases will respond to ipilimumab treatment while being safe and well-tolerated.

Condition	Intervention	Phase
Melanoma	Drug: Ipilimumab	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases

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 [ Time Frame: time between the randomization date and the date of progression or death, whichever occurs first ] [ Designated as safety issue: No ]
Incidence of MRI defined brain edema [ Time Frame: D1W1, D36W6, D85W12, D134W18, Maintenance W24, +6WKS and End of treatment ] [ Designated as safety issue: Yes ]
Safety and tolerability of treatment [ Time Frame: throughout study, grading via CTCAE 3.0 ] [ Designated as safety issue: Yes ]
Response of tumor in presence or absence of corticosteroids [ Time Frame: Objective Response Rate & Disease Control Rate in metastatic brain melanoma lesions using IR criteria after Wk 12. Analysis of best overall ORR, CR and PR (mWHO) or irPR (IR) no less than 4 weeks after criteria for response are first met ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ipilimumab IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, Eligible subjects will receive ipilimumab during the Induction or Maintenance phases until one or more of the following criteria are met: (1) protocol defined progression (irPD) of the global tumor burden is demonstrated, (2) subject develops a related adverse event which requires discontinuation of ipilimumab therapy, (3) the investigator observes evidence of clinical deterioration that indicates further subject benefit from ipilimumab therapy is unlikely or requires a change to an alternative therapy, or (4) the subject withdraws consent

Arms

Assigned Interventions

1: Experimental

Drug: Ipilimumab

IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, Eligible subjects will receive ipilimumab during the Induction or Maintenance phases until one or more of the following criteria are met: (1) protocol defined progression (irPD) of the global tumor burden is demonstrated, (2) subject develops a related adverse event which requires discontinuation of ipilimumab therapy, (3) the investigator observes evidence of clinical deterioration that indicates further subject benefit from ipilimumab therapy is unlikely or requires a change to an alternative therapy, or (4) the subject withdraws consent

Eligibility

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

Criteria

Inclusion Criteria:

Malignant melanoma with measurable brain metastases
ECOG 0-1
Stable labs
≥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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Arizona
Local Institution	Not yet recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site 019
United States, California
Local Institution	Not yet recruiting
Duarte, California, United States, 91010
Contact: Site 002
The Angeles Clinic & Research Institute	Recruiting
Los Angeles, California, United States, 90025
Contact: Omid Hamid, Site 004
Local Institution	Not yet recruiting
San Francisco, California, United States, 94143
Contact: Site 021
United States, Connecticut
Yale University School Of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Mario Sznol, Site 003 203-785-6221
United States, Illinois
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Joseph Clark, Site 008
Oncology Specialists, S.C.	Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jon Richards, Site 012
United States, Indiana
Indiana University Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore Logan, Site 011
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: F.Stephen Hodi, Site 006
United States, Michigan
Local Institution	Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Site 015
United States, New Hampshire
Dartmouth Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Marc Ernstoff, Site 010
United States, New York
Local Institution	Not yet recruiting
Bronx, New York, United States, 10469
Contact: Site 017
Mem Sloan-Ket Can Ctr	Recruiting
New York, New York, United States, 10021
Contact: Jedd D. Wolchok, Site 020
United States, Oregon
Providence Portland Med Ctr	Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 016
United States, Pennsylvania
Local Institution	Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15228
Contact: Site 013
United States, Tennessee
Vanderbilt Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Igor Puzanov, Site 001 615-322-4967
United States, Virginia
Local Institution	Not yet recruiting
Charlottesvillle, Virginia, United States, 22908
Contact: Site 005
United States, Washington
Seattle Can Care Alliance	Recruiting
Seattle, Washington, United States, 98109
Contact: John A. Thompson, Site 018

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

Investigators

Study Director:

Bristol-Myers Squibb

More Information

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA184-042
Study First Received:	February 19, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00623766
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009