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Compassionate Use Trial for Unresectable Melanoma With Ipilimumab
Expanded access is currently available for this treatment.
Verified December 2011 by Bristol-Myers Squibb

First Received on June 29, 2007.   Last Updated on December 20, 2011   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by (Responsible Party): Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00495066
  Purpose

The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab for eligible subjects, including those previously enrolled in Ipilimumab studies MDX010-16 or MDX010-20.


Condition Intervention
Melanoma
Drug: Ipilimumab

Study Type: Expanded Access     What is 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:

Intervention Details:
    Drug: Ipilimumab
    Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; 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

Inclusion Criteria:

  • Signed Written Informed Consent
  • Histologically confirmed Stage III (unresectable) or Stage IV melanoma
  • 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
  • Subjects with asymptomatic brain metastases are eligible
  • Primary ocular and mucosal melanomas are allowed
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0- 2
  • Life expectancy ≥ 16 weeks
  • Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, pelvis, and bone scans
  • Required values for initial laboratory tests:

    1. White Blood Cells (WBC): ≥ 2000/uL (≥ 2 x 10*9*/L)
    2. Antigen Neutrophil Count (ANC): ≥ 1000/uL (≥ 1 x 10*9*/L)
    3. Platelets: ≥ 75 x 103/uL (≥ 75 x 10*9*/L)
    4. Hemoglobin: ≥ 9 g/dL (≥ 80 g/L; may be transfused)
    5. Creatinine: ≤ 2.0 x ULN
  • Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT):≤ 2.5 x Upper Limit of Normal (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)
  • Men and women, at least 16 years of age
  • Prior treatment with an anti-Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) drug is allowed provided therapy was not discontinued to to drug-related toxicity

Exclusion Criteria:

  • Women of Child-Bearing Potential (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
  • WOCBP using a prohibited contraceptive method
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or before investigational product administration
  • Subjects on any other systemic therapy for cancer, including any other experimental treatment
  • Prior treatment with an anti CTLA 4 antibody if treatment failure was due to Immune-Related Adverse Events (irAEs) or discontinuation was due to an Adverse Event (AE)/Serious Adverse Event (SAE)
  • 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
  • Presence of active autoimmune disease
  • Presence of known hepatitis B or hepatitis C (active) infection, regardless of control on antiviral therapy
  • Any subject who has a life threatening condition that requires high-dose immunosuppressants
  • 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
  • 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
  • Any subject enrolled in a registrational study (ie, CA184-024) that has a survival as a primary 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495066

Contacts
Contact: For participation information at a USA site use a phone number .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
Argentina
Centro Medico Austral
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1019ABS
Contact: Ricardo Santos, Site 127     541148117540        
Hospital Britanico De Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, CIZ80AEB
Contact: Carlos Silva, Site 126     5491148091439        
Instituto de Oncología Angel Roffo, Universidad de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1417
Contact: Gabriela Cinat, Site 125     541155802811 or 54115216233        
Centro Oncologico de Rosario
Rosario, Santa Fe, Argentina, S2000KZE
Contact: Luis Fein, Site 152     543414218909        
Brazil
Instituto ÉTICA - AMO - Assistência Multidisciplinar em Oncologia
Salvador, Bahia, Brazil, 41950-610
Contact: Bruno Setenta, Site 134     557130218734        
Instituto do Cancer do Ceara
Fortaleza, Ceara, Brazil, 60930-230
Contact: Flavio Bitencourt, Site 135     558532884576        
Hospital Sao Lucas das PUCRS
Porto Alegre, Rio Grande do Sul (RS), Brazil, 90610-000
Contact: Carlos Henrique Escosteguy Barrios, Site 136     555133203039        
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul (RS), Brazil, 90840440
Contact: Sergio Jobim de Azevedo, Site 148     555132523930 and 555132523931        
Amaral Carvalho hospital
Jau, Sao Paulo, Brazil, 17210-120
Contact: Edilaine Sabio, Site 141     551436021399        
Fundacao Pio XI - Hospital De Cancer De Barretos
Barretos, SP, Brazil, 14784-400
Contact: Sergio Vicente Serrano, Site 144     551733216637        
Hospital Sao Jose - Beneficencia Portuguesa - Oncology Center
Sao Paulo, SP, Brazil, CEP 01321-001
Contact: Antonio Carlos Buzaid, Site 149            
Hospital A. C. Camargo
Sao Paulo, SP, Brazil, 01509-900
Contact: Jose Augusto Rinck Junior, Site 142     551121895188        
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil, 20231-050
Contact: Daniel Herchenhorn, Site 139     552132076567        
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4N2
Contact: Site 108            
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 106            
Canada, British Columbia
Local Institution
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Site 131            
Local Institution
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 122            
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Site 111            
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 146            
Local Institution
London, Ontario, Canada, N6A 4L6
Contact: Site 132            
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site 129            
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 133            
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, G1R 2J6
Contact: Site 145            
Local Insitution
Montreal, Quebec, Canada, H2W 1S6
Contact: Site 112            
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 112            
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
ClinicalTrials.gov Identifier: NCT00495066     History of Changes
Other Study ID Numbers: CA184-045
Study First Received: June 29, 2007
Last Updated: December 20, 2011
Health Authority: Canada: Health Canada;   Argentina: Ministry of Health;   Brazil: Agencia Nacional de Vigilancia Sanitaria;   United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 09, 2012