Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00495066
First received: June 29, 2007
Last updated: May 30, 2013
Last verified: May 2013
  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 at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, 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 Expanded Access Use of Ipilimumab (BMS-734016) Monotherapy in Subjects With Unresectable Stage III or Stage 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, and pelvis. Bone scans should be completed if clinically indicated. The images can be accepted if obtained 6 weeks before initiation of Ipilimumab
  • 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
  • Women of childbearing potential (WOCBP) and their partners must use highly effective methods of birth control (double barrier, e.g, condom or diaphragm or cervical cap associated with spermicide or intrauterine device combined with another form of birth control) for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at Screening and within 24 hours prior to the start of investigational product
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile
  • Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized

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 12 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
  • Subjects from studies CA184-042, CA184-078 or CA184-087, who are being followed for survival only or for scans only are not eligible for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495066

Locations
Brazil
Instituto ÉTICA - AMO - Assistência Multidisciplinar em Oncologia
Salvador, Bahia, Brazil, 41950-610
Instituto do Cancer do Ceara
Fortaleza, Ceara, Brazil, 60930-230
Hospital Sao Lucas das PUCRS
Porto Alegre, Rio Grande do Sul (RS), Brazil, 90610-000
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul (RS), Brazil, 90840440
Amaral Carvalho hospital
Jau, Sao Paulo, Brazil, 17210-120
Fundacao Pio XI - Hospital De Cancer De Barretos
Barretos, SP, Brazil, 14784-400
Hospital Sao Jose - Beneficencia Portuguesa - Oncology Center
Sao Paulo, SP, Brazil, CEP 01321-001
Hospital A. C. Camargo
Sao Paulo, SP, Brazil, 01509-900
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil, 20231-050
Sponsors and Collaborators
Bristol-Myers Squibb
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: NCT00495066     History of Changes
Other Study ID Numbers: CA184-045
Study First Received: June 29, 2007
Last Updated: May 30, 2013
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 September 16, 2014