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Ticilimumab (CP-675,206) in Treating Patients With Stage IIIC or Stage IV Melanoma
Bu çalışma, ileri evre (Evre IIIC veya Evre IV) melanom (melanoma) yani bir tür cilt kanseri olan hastalarda Ticilimumab (CP-675,206) ilacını incelemektedir. Çalışmaya, cerrahi olarak tümüyle tedavi edilemeyen, biyopsi alınabilecek lezyonları bulunan melanom hastaları katılabilmiştir. Jonsson Comprehensive Cancer Center tarafından yürütülen çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.