A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05)

被引:83
作者
Butowski, Nicholas [1 ]
Chang, Susan M. [1 ]
Junck, Larry [2 ]
DeAngelis, Lisa M. [3 ]
Abrey, Lauren [3 ]
Fink, Karen [4 ]
Cloughesy, Tim [5 ]
Lamborn, Kathleen R. [1 ]
Salazar, Andres M. [6 ]
Prados, Michael D. [1 ]
机构
[1] Univ Calif San Francisco, Dept Neurol Surg, San Francisco, CA 94143 USA
[2] Univ Michigan, Dept Neurol, Ann Arbor, MI 48109 USA
[3] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
[4] Baylor Univ, Dallas, TX 75246 USA
[5] Univ Calif Los Angeles, Los Angeles, CA 90095 USA
[6] Oncovir Inc, Washington, DC 20008 USA
关键词
Glioblastoma multiforme; Radiation therapy; Adjuvant therapy; Poly-ICLC; DOUBLE-STRANDED-RNA; POLYINOSINIC-POLYCYTIDYLIC ACID; TOLL-LIKE RECEPTOR-3; PROTEIN-KINASE; L-LYSINE; MALIGNANT GLIOMA; ADJUVANT TEMOZOLOMIDE; SUPPRESSOR FUNCTION; ACTIVATED ENZYMES; CELL CARCINOMA;
D O I
10.1007/s11060-008-9693-3
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This phase II study was designed to determine the overall survival time of adults with supratentorial glioblastoma treated with the immune modulator, polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC), in combination with and following radiation therapy (RT). Methods and materials This was an open-label, single arm phase II study. Patients were treated with RT in combination with poly-ICLC followed by poly-ICLC as a single agent. Poly-ICLC was initiated 7-28 days after the surgical procedure that established the diagnosis; radiotherapy began within 7 days of the first dose of poly-ICLC and within 35 days of surgical diagnosis. Treatment with poly-ICLC continued following the completion of RT to a maximum of 1 year or until tumor progression. Results 31 patients were enrolled in this study. One patient did not have a Glioblastoma mutiforme and was deemed ineligible. For the 30 eligible patients, time to progression was known for 27 patients and 3 were censored. The estimated 6-month progression-free survival was 30% and the estimated 1-year progression-free survival was 5%. Median time to progression was as 18 weeks. The 1-year survival was 69% and the median survival was 65 weeks. Conclusions The combined therapy was relatively well-tolerated. This study suggests a survival advantage compared to historical studies using RT without chemotherapy but no survival advantage compared to RT with adjuvant nitrosourea or non-temozolomide chemotherapy. Our results suggest that poly-ICLC has activity against glioblastoma and may be worth further study in combination with agents such as temozolomide.
引用
收藏
页码:175 / 182
页数:8
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