Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: CP-675,206
Intervention description: Patients will receive intravenous administration of CP-675,206 at a dose of 15mg/kg on Day 1 of an every 90 day cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 day period. Patients may receive up to 8 dose (8 cycles) in a 24-month period until progression of disease or intolerable toxicity.
Intervention MeSH terms: Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Monoclonal antibodies, such as ticilimumab (CP-675,206), can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them.

      PURPOSE: This phase II trial is studying how well ticilimumab (CP-675,206) works in treating
      patients with stage IIIC or stage IV melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed melanoma that is surgically incurable and either:

               -  Stage IIIc melanoma including locally relapsed, satellite, in-transit lesions or
                  bulky draining lymph node metastasis.

               -  Stage IV melanoma (M1a, M1b, M1c) with accessible lesions for biopsy.

          -  At least 2 lesions amenable for outpatient biopsies

          -  No restriction based on prior treatments

          -  Disease progression after the last dose of prior therapy

          -  A minimum of one measurable lesion defined as:

               -  Meeting the criteria for measurable disease according to Response Evaluation
                  Criteria in Solid Tumors

               -  Skin lesion(s) selected as non-completely biopsied target lesions that can be
                  accurately measured and recorded by color photography with a ruler to document
                  the size of the target lesion(s).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate bone marrow and hepatic function determined within 30 days prior to
             enrollment, defined as:

               -  Absolute neutrophil count > 1.0 x 10^9 cells/L

               -  Platelets > 90 x 10^9 /L

               -  Hemoglobin > 9 g/L

               -  Aspartate and alanine aminotransferases < 2.5 x upper limit of normal (ULN) (< 5
                  x ULN, if documented liver metastases are present)

               -  Total bilirubin < 2 x ULN (except patients with documented Gilbert's syndrome)

          -  Must be willing and able to provide writing informed consent.

          -  Must be willing and able to accept at least two tumor biopsies.

          -  Must be willing and able to accept at least two leukapheresis procedures.

        Exclusion Criteria:

          -  Received treatment for cancer, including immunotherapy, within one month prior to
             dosing.

          -  Previous participation in Pfizer study A3671009: A Phase 3, Open Label, Randomized
             Comparative Study of CP-675,206 and Either Dacarbazine or Temozolomide in Patients
             with Advanced Melanoma

          -  Eligible for enrollment to Pfizer A3671008: A Phase 2, Open Label, Single Arm Study to
             Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of CP-675,206 in
             Patients with Advanced Refractory and/or Relapsed Melanoma

          -  History of significant evidence of risk for chronic inflammatory or autoimmune
             disease. Patents will be eligible if prior autoimmune disease of the hypophysis was
             treated locally or have resulted in fibrotic damage requiring thyroid hormone
             replacement. Vitiligo will not be a basis for exclusion.

          -  History of inflammatory bowel disease, celiac disease, or other chronic
             gastrointestinal conditions associated with diarrhea or bleeding, or current acute
             colitis or any origin

          -  Potential requirement for systemic corticosteroids or concurrent immunosuppressive
             drugs based on prior history or received systemic steroids within the last 4 weeks
             prior to enrollment

          -  Dementia or significantly altered mental status that would prohibit the understanding
             or rendering of informed consent and compliance with the requirements of this protocol

          -  Clinically active brain metastases. Radiological documentation of absence of brain
             metastases at screening is required for all patients

          -  Pregnancy or breast-feeding.