Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days after Neuradiab administration in patients with a first or second recurrence of glioblastoma multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant glioma.

开始日期2009-05-01

申办/合作机构

Bradmer Pharmaceuticals, Inc.

NCT00615186 / Terminated临床3期

A Phase III Randomized Study of Neuradiab in Combination With External Beam Radiation and Temozolomide Versus External Beam Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

The current study will investigate whether the addition of Neuradiab to surgery, radiation and adjuvant chemotherapy (temozolomide) will improve the survival of patients with glioblastoma and whether the drug regimen is safe.

开始日期2008-06-01

申办/合作机构

Bradmer Pharmaceuticals, Inc.

100 项与 Anti-tenascin monoclonal antibody 81C6-I-131(Duke University Medical Center) 相关的临床结果

登录后查看更多信息

100 项与 Anti-tenascin monoclonal antibody 81C6-I-131(Duke University Medical Center) 相关的转化医学

登录后查看更多信息

100 项与 Anti-tenascin monoclonal antibody 81C6-I-131(Duke University Medical Center) 相关的专利（医药）

登录后查看更多信息

项与 Anti-tenascin monoclonal antibody 81C6-I-131(Duke University Medical Center) 相关的文献（医药）

2008-05-01·Methods and findings in experimental and clinical pharmacology

Gateways to clinical trials.

作者: Moral, M A ; Tomillero, A

11D10, 9vPnC-MnCc; Adalimumab, Adefovir dipivoxil, Alefacept, ALN-RSV01, AME-133, AMG-317, Aminolevulinic acid methyl ester, Amlodipine besylate/atorvastatin calcium, Anisodamine, Anti-IL-5 receptor antibody, Apremilast, Aripiprazole, Atacicept, Atazanavir sulfate, Atrasentan; Banoxantrone, Bevacizumab, BIBW-2992, Binodenoson, BMS-387032; cAC10, Caldaret hydrate, CD-NP, Ceftobiprole medocaril, Celivarone fumarate, Certolizumab pegol, Cholesteryl hydrophobized polysaccharide-Her2 protein complex, Choline fenofibrate, Cilengitide, Cinaciguat, Curcumin, Custirsen sodium, Cypher, CYT-6091; Dalcetrapib, Deforolimus, Desvenlafaxine succinate, DHA-paclitaxel, DP6-001; E-7010, E75, Ecogramostim, EGF-P64K, EnvPro, Enzastaurin hydrochloride, Escitalopram oxalate, Ezetimibe, Ezetimibe/simvastatin; Fenretinide; Gefitinib, Golimumab, Green tea catechins, GTI-2040, GW-406381; HPV16 E6 E7, HPV-16/18 AS04, HPV-6/11/16/18; ICC-1132, Immune globulin intravenous (human), Indacaterol, Intranasal insulin; Kahalalide F; Lactobacillus rhamnosus, Laromustine, Laropiprant, GTI-2040; MAb 3H1, Mepolizumab, Mifamurtide, Milataxel, MP4; Nebicapone, Nelarabine, Neuradiab; Oncolytic HSV; PCV7, PHX-1149, Pimecrolimus, Pralatrexate, Pramiconazole; Ranibizumab, Reolysin, Rilonacept, Rolofylline, Romidepsin; S-32865, Shigella dysenteriae 1 vaccine; Taranabant, Taxus, TZP-101; Ustekinumab; Vitespen; Zileuton, Zycure.

2007-05-01·Nuclear medicine and biology4区 · 医学

Tumor resection cavity administered iodine-131-labeled antitenascin 81C6 radioimmunotherapy in patients with malignant glioma: neuropathology aspects

4区 · 医学

Article

作者: Michael R. Zalutsky ; Henry S. Friedman ; Ilkcan Cokgor ; Linda Cleveland ; Roger E. McLendon ; James E. Herndon ; David A. Reardon ; Darell D. Bigner ; Susan T. Boulton ; Carol Wikstrand ; Gamal Akabani ; Allan H. Friedman

INTRODUCTION:

The neurohistological findings in patients treated with targeted beta emitters such as (131)I are poorly described. We report a histopathologic analysis from patients treated with combined external beam therapy and a brachytherapy consisting of a (131)I-labeled monoclonal antibody (mAb) injected into surgically created resection cavities during brain tumor resections.

METHODS:

Directed tissue samples of the cavity walls were obtained because of suspected tumor recurrence from 28 patients. Samples and clinical follow-up were evaluated on all patients (Group A) based on total radiation dose received and a subset of these (n=18; Group B, proximal therapy subset) who had received external beam therapy within

RESULTS:

The lesions observed after (131)I-mAb therapy were qualitatively similar to those reported for other types of radiation therapy; however, the high localized dose rate and absorbed doses produced by the short range of (131)I beta particles seem to have resulted in an earlier necrotic reaction in the tumor bed. Among all 28 (Group A) patients, median survival from tissue analysis after mAb therapy depended on histopathology and total radiation absorbed dose. Median survival for patients with tissue classified as proliferative glioma, quiescent glioma and negative for neoplasm were 3.5, 15 and 27.5 months, respectively. Without categorization, total dose was a significant predictor of survival (P<.002) where patients with higher doses had better prognoses. For example, median survival in patients receiving a total radiation dose greater than 86 Gy was 19 months compared with 7 months for those receiving less than 86 Gy.

CONCLUSIONS:

Histopathologic analysis correlated with prognosis. Among all patients (Group A) there was a significant correlation between biopsy outcome, survival, and total radiation absorbed dose. Among the Group B proximal therapy patients, the neuropathologic changes were qualitatively similar to those described for external beam therapy and interstitial brachytherapy.

2006-01-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology1区 · 医学

Salvage Radioimmunotherapy With Murine Iodine-131–Labeled Antitenascin Monoclonal Antibody 81C6 for Patients With Recurrent Primary and Metastatic Malignant Brain Tumors: Phase II Study Results

1区 · 医学

Article

作者: Bigner, Darell D. ; McLendon, Roger E. ; Guruangan, Sri ; Friedman, Henry S. ; Zhao, Xiao-Guang ; Dowell, Jeanette M. ; Coleman, R. Edward ; Desjardins, Annick ; Wong, Terence Z. ; Rich, Jeremy N. ; Friedman, Allan H. ; Zalutsky, Michael R. ; Badruddoja, Michael ; Pegram, Charles N. ; Provenzale, James M. ; Vredenburgh, James J. ; Quinn, Jennifer A. ; Akabani, Gamal ; Herndon, James E. ; Reardon, David A.

Purpose:

To assess the efficacy and toxicity of intraresection cavity iodine-131–labeled murine antitenascin monoclonal antibody 81C6 (131I-m81C6) among recurrent malignant brain tumor patients.

Patients and Methods:

In this phase II trial, 100 mCi of 131I-m81C6 was injected directly into the surgically created resection cavity (SCRC) of 43 patients with recurrent malignant glioma (glioblastoma multiforme [GBM], n = 33; anaplastic astrocytoma [AA], n = 6; anaplastic oligodendroglioma [AO], n = 2; gliosarcoma [GS], n = 1; and metastatic adenocarcinoma, n = 1) followed by chemotherapy.

Results:

With a median follow-up of 172 weeks, 63% and 59% of patients with GBM/GS and AA/AO tumors were alive at 1 year. Median overall survival for patients with GBM/GS and AA/AO tumors was 64 and 99 weeks, respectively. Ten patients (23%) developed acute hematologic toxicity. Five patients (12%) developed acute reversible neurotoxicity. One patient (2%) developed irreversible neurotoxicity. No patients required reoperation for radionecrosis.

Conclusion:

In this single-institution phase II study, administration of 100 mCi of 131I-m81C6 to recurrent malignant glioma patients followed by chemotherapy is associated with a median survival that is greater than that of historical controls treated with surgery plus iodine-125 brachytherapy. Furthermore, toxicity was acceptable. Administration of a fixed millicurie dose resulted in a wide range of absorbed radiation doses to the SCRC. We are now conducting a phase II trial, approved by the US Food and Drug Administration, using patient-specific 131I-m81C6 dosing, to deliver 44 Gy to the SCRC followed by standardized chemotherapy. A phase III multicenter trial with patient-specific dosing is planned.

100 项与 Anti-tenascin monoclonal antibody 81C6-I-131(Duke University Medical Center) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16197

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
多形性胶质母细胞瘤	临床3期	-	Bradmer Pharmaceuticals, Inc.	2008-06-01
胶质母细胞瘤	临床3期	美国	Bradmer Pharmaceuticals, Inc.	-
胶质母细胞瘤	临床3期	-	Duke University Medical Center	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2004	临床2期	脑癌	42	Iodine 131-labeled murine anti-tenascin antibody 81C6	襯齋鏇製繭壓襯製醖膚(壓餘繭築廠顧願鬱壓築) = 膚築廠積壓觸獵廠繭憲簾艱窪艱餘製顧窪廠網 (繭窪簾蓋夢選鏇壓膚壓 )	积极	2004-07-15
				Metformin use after BC diagnosis	-