دورية أكاديمية
أعرض في EDS

Phase I trial of tremelimumab in combination with short-term androgen deprivation in patients with PSA-recurrent prostate cancer.

التفاصيل البيبلوغرافية
العنوان: Phase I trial of tremelimumab in combination with short-term androgen deprivation in patients with PSA-recurrent prostate cancer.
المؤلفون: McNeel DG; University of Wisconsin Carbone Cancer Center, Madison, 53792, USA. dm3@medicine.wisc.edu, Smith HA, Eickhoff JC, Lang JM, Staab MJ, Wilding G, Liu G
المصدر: Cancer immunology, immunotherapy : CII [Cancer Immunol Immunother] 2012 Jul; Vol. 61 (7), pp. 1137-47. Date of Electronic Publication: 2011 Dec 31.
نوع المنشور: Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
اللغة: English
بيانات الدورية: Publisher: Springer Verlag Country of Publication: Germany NLM ID: 8605732 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0851 (Electronic) Linking ISSN: 03407004 NLM ISO Abbreviation: Cancer Immunol Immunother Subsets: MEDLINE
أسماء مطبوعة: Publication: Berlin : Springer Verlag
Original Publication: Berlin ; New York, NY : Springer International, c1982-
مواضيع طبية MeSH: Androgen Antagonists/*administration & dosage , Anilides/*administration & dosage , Antibodies, Monoclonal/*administration & dosage , Antineoplastic Combined Chemotherapy Protocols/*administration & dosage , Nitriles/*administration & dosage , Prostate-Specific Antigen/*blood , Prostatic Neoplasms/*drug therapy , Tosyl Compounds/*administration & dosage, Aged ; Anilides/adverse effects ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Disease Progression ; Dose-Response Relationship, Drug ; Humans ; Male ; Middle Aged ; Nitriles/adverse effects ; Prostate-Specific Antigen/immunology ; Prostatic Neoplasms/blood ; Prostatic Neoplasms/pathology ; Prostatic Neoplasms/surgery ; Tosyl Compounds/adverse effects ; Treatment Outcome
مستخلص: CTLA-4 blockade has demonstrated antitumor efficacy in human clinical trials. The antitumor mechanism is presumably mediated in part by the expansion of tumor-specific T cells. Androgen deprivation, the cornerstone of treatment for patients with metastatic prostate cancer, has been shown to elicit prostate tissue apoptosis and lymphocytic inflammation. We hypothesized that treatment with androgen deprivation, followed by an anti-CTLA-4 antibody, could augment a tumor-specific immune response elicited by androgen deprivation. We report here the results of a phase I trial evaluating a humanized monoclonal antibody targeting CTLA-4, CP-675,206 (tremelimumab), in combination with androgen deprivation using an antiandrogen. Eligible patients were those with PSA-recurrent prostate cancer after primary surgery and/or radiation therapy, not previously treated with androgen deprivation, and without radiographic evidence of metastatic disease. Subjects were treated in two cycles, 3 months apart, in which they received bicalutamide 150 mg daily days 1-28 and tremelimumab on day 29. The primary endpoint of the trial was safety. Secondary endpoints included measures of PSA kinetics and identification of a maximum tolerated dose. Eleven patients were enrolled and completed at least 1 year of follow-up. Dose-limiting toxicities included grade 3 diarrhea and skin rash. No favorable changes in PSA doubling time were observed in a period shortly after completing treatment; however, three patients experienced a prolongation in PSA doubling time detectable several months after completing treatment. The identification of delayed, prolonged favorable changes in serum PSA suggests that future studies could explore this combination in studies evaluating time to disease progression.
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معلومات مُعتمدة: P30 CA014520 United States CA NCI NIH HHS; T32 CA009614 United States CA NCI NIH HHS; T32 CA009614-21 United States CA NCI NIH HHS; T32CA009614 United States CA NCI NIH HHS
المشرفين على المادة: 0 (Androgen Antagonists)
0 (Anilides)
0 (Antibodies, Monoclonal)
0 (Antibodies, Monoclonal, Humanized)
0 (Nitriles)
0 (Tosyl Compounds)
A0Z3NAU9DP (bicalutamide)
EC 3.4.21.77 (Prostate-Specific Antigen)
QEN1X95CIX (tremelimumab)
تواريخ الأحداث: Date Created: 20120103 Date Completed: 20130110 Latest Revision: 20220331
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC3349783
DOI: 10.1007/s00262-011-1193-1
PMID: 22210552
قاعدة البيانات: MEDLINE
الوصف
تدمد:1432-0851
DOI:10.1007/s00262-011-1193-1