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Compassionate Use Trial for Unresectable Melanoma With Ipilimumab (IMEXA)
Expanded access is temporarily not available for this treatment.
First Received: June 29, 2007   Last Updated: February 3, 2010   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00495066
  Purpose

Primary objective is to provide treatment with ipilimumab to subjects who have unresectable Stage III or Stage IV melanoma, who have no alternative treatment options and whose physicians believe that it is appropriate to administer ipilimumab at a dose of 10 mg/kg induction/maintenance


Condition Intervention
Melanoma
Drug: Ipilimumab

Study Type: Expanded Access
Official Title: A Multicenter Treatment Protocol for Compassionate Use of Ipilimumab in Subjects With Unresectable Stage III or IV Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ipilimumab
    Intravenous Solution, Intravenous, Ipilimumab 10mg/kg, Ipilimumab - one dose every 3 wks for 10 wks then one dose every 12 wks starting at Wk 24; Until disease progression, unacceptable toxicity or withdrawal of consent
  Eligibility

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

IMEXA Call Center 1-866-518-4599

Inclusion:

Signed Written Informed Consent

  1. Histologically confirmed Stage III (unresectable) or Stage IV melanoma
  2. Must have failed at least one systemic therapy for malignant melanoma or be intolerant to at least one prior systemic treatment. Note: Enrollees must not be eligible for a clinical study with ipilimumab
  3. Subjects with brain metastases are allowed
  4. Primary ocular and mucosal melanomas are allowed
  5. Must be at least 28 days since treatment with chemotherapy, biochemotherapy, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment. Must have recovered from prior surgery or radiation. Systemic corticosteroids should be eliminated or weaned to the minimum dose before starting ipilimumab treatment. Consult with the Medical Monitor for individual subjects
  6. ECOG PS 0- 2
  7. Life expectancy ≥ 16 weeks
  8. Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, pelvis, and bone scans
  9. Required values for initial laboratory tests:

    WBC: ≥ 2000/uL (≥ 2 x 10*9*/L) ANC: ≥ 1000/uL (≥ 1 x 10*9*/L) Platelets: ≥ 75 x 103/uL (≥ 75 x 10*9*/L) Hemoglobin: ≥ 9 g/dL (≥ 80 g/L; may be transfused) Creatinine: ≤ 2.0 x ULN AST/ALT: ≤ 2.5 x ULN for subjects without liver metastasis ≤ 5 times for liver metastases Bilirubin: ≤ 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL)

  10. Men and women, at least 16 years of age

Exclusion Criteria:

  1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the last dose of investigational product
  2. WOCBP using a prohibited contraceptive method
  3. Women who are pregnant or breastfeeding
  4. Women with a positive pregnancy test on enrollment or before investigational product administration
  5. Subjects on any other systemic therapy for cancer, including any other experimental treatment
  6. Prior treatment with an anti CTLA 4 antibody if treatment failure was due to irAEs or discontinuation was due to an AE/SAE
  7. Any subject enrolled in a registrational study (ie, CA184024) that has a survival endpoint should not be enrolled in CA184-045. Also, if a subject is eligible for a treatment study, he or she is not eligible for this study
  8. Presence of active autoimmune disease
  9. Presence of known hepatitis B or hepatitis C (active) infection, regardless of control on antiviral therapy
  10. Subjects with melanoma who have another active, concurrent, malignant disease, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  11. Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495066

  Hide Study Locations
Locations
United States, Alabama
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Univ Of Ark For Med Sci
Little Rock, Arkansas, United States, 72205
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Moores Ucsd Cancer Center
La Jolla, California, United States, 92093
The Angeles Clinic & Research Institute, Inc
Los Angeles, California, United States, 90025
San Francisco Oncology Associates
San Francisco, California, United States, 94115
City Of Hope
Duarte, California, United States, 91010
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Neil M. Barth, Md, Inc
Newport Beach, California, United States, 92663
East Valley Hematology Oncology Medical Group
Burbank, California, United States, 91505
St Mary'S Medical Center
San Francisco, California, United States, 84117
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
Local Institution
Loma Linda, California, United States, 92354
Redwood Regional Medical Group Inc.
Santa Rosa, California, United States, 95403
Bartosz Chmielowski, Md
Los Angeles, California, United States, 90095
Facey Medical Foundation
Mission Hills, California, United States, 91345
Pacific Coast Hematology/ Oncology Med Group, Inc
Fountain Valley, California, United States, 92708
Local Institution
Anaheim, California, United States, 92801
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
U Of Col Health Sci. Cnt
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Connecticut
St Fran Hosp & Med Cnt
Hartford, Connecticut, United States, 06105
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
H Lee Moffit Cancer Cnt And Res Inst
Tampa, Florida, United States, 33612
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Hematology & Oncology Consultants, Pa
Orlando, Florida, United States, 32804
Lake Cnt Oncol & Hematol
Tavares, Florida, United States, 32778
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Local Institution
The Villages, Florida, United States, 32159
Hematology & Medical Oncology Of Southern Palm Beach County
Boynton Beach, Florida, United States, 33435
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Loyola University Chicago
Maywood, Illinois, United States, 60153
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
Local Institution
Chicago, Illinois, United States, 60637
United States, Indiana
Goshen Health System
Goshen, Indiana, United States, 46526
Oncology Hematology Associates Of Sw In
Newburgh, Indiana, United States, 47630
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
United States, Maryland
H & J Weinberg Can Int @ Franklin Square
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
U Of Missouri Cancer Cnt
Columbia, Missouri, United States, 65203
Medical Oncology/Washington University School Of Medicine
St Louis, Missouri, United States, 63110
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89135
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Local Institution
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Cancer Resch & Treat Ctr
Albuquerque, New Mexico, United States, 87131
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Montefiore Medical Center
Bronx, New York, United States, 10466
Mem Sloan-Ket Can Ctr
New York, New York, United States, 10021
Nyu Clinical Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Blumenthal Cancer Cnt
Charlotte, North Carolina, United States, 28203
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
Carolina Cancer Management, Inc
Fayetteville, North Carolina, United States, 28304
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Mid Ohio Onc/Hema, Inc., Dba
Columbus, Ohio, United States, 43219
Hematology Oncology Consultants, Inc
Columbus, Ohio, United States, 43235
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abramson Cancer Center Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Lowcountry Hematology & Oncology, P.A.
Mt. Pleasant, South Carolina, United States, 29464
Musc Hema/Onco Division
Charleston, South Carolina, United States, 250635
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
Thompson Canc Surv Cnt
Knoxville, Tennessee, United States, 37916
United States, Texas
Jose A. Figueroa, Md
Lubbock, Texas, United States, 79410
Arlington Cancer Center
Arlington, Texas, United States, 76012
The University Of Texas
Houston, Texas, United States, 77030
Cancer Care Centers Of South Texas
Kerrville, Texas, United States, 78028
United States, Virginia
Local Institution
Charlottesvillle, Virginia, United States, 22908
United States, Washington
Providence Cancer Center
Spokane, Washington, United States, 99204
Multicare Health System
Tacoma, Washington, United States, 98405
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Seattle Can Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA184-045
Study First Received: June 29, 2007
Last Updated: February 3, 2010
ClinicalTrials.gov Identifier: NCT00495066     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 08, 2010