Literature DB >> 9817277

Phase I trial of O6-benzylguanine for patients undergoing surgery for malignant glioma.

H S Friedman1, D M Kokkinakis, J Pluda, A H Friedman, I Cokgor, M M Haglund, D M Ashley, J Rich, M E Dolan, A E Pegg, R C Moschel, R E McLendon, T Kerby, J E Herndon, D D Bigner, S C Schold.   

Abstract

PURPOSE: The major mechanism of resistance to alkylnitrosourea therapy is the DNA repair protein O6-alkylguanine-DNA alkyltransferase (AGT), which removes chlorethylation or methylation damage from the O6-position of guanine. O6-benzylguanine (O6-BG) is an AGT substrate that inhibits AGT by suicide inactivation. We conducted a phase I trial to define the presurgical dose required for depletion of tumor AGT activity in patients with malignant glioma.
MATERIALS AND METHODS: Patients were to be treated 18 hours before craniotomy with intravenous doses that ranged between 40 and 100 mg/m2 given over 1 hour. Resected tumor was snap-frozen in liquid nitrogen and AGT activity analyzed by high-pressure liquid chromatography (HPLC). Up to 13 patients were treated at a specific dose of O6-BG, with a target end point of > or = 11 of 13 patients with undetectable tumor AGT levels (< 10 fmol/mg protein).
RESULTS: Thirty patients with malignant gliomas were enrolled, with 11 of 11 patients treated at 100 mg/m2 O6-BG demonstrating tumor AGT levels less than 10 fmol/mg protein. No toxicity was noted in any patient treated.
CONCLUSION: These results indicate that 100 mg/m2 of O6-BG can maintain tumor AGT levels less than 10 fmol/mg protein for at least 18 hours after treatment, a time interval in which bis(2-chloroethyl)nitrosourea (BCNU)-induced chloroethyl adducts are fully converted into interstrand cross-links. A 100-mg/m2 dose of O6-BG will be used in combination with BCNU in another phase I trial designed to determine the maximal-tolerated dose of BCNU.

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Year:  1998        PMID: 9817277     DOI: 10.1200/JCO.1998.16.11.3570

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN: 0732-183X            Impact factor:   44.544


  41 in total

1.  Phase 0 and window of opportunity clinical trial design in neuro-oncology: a RANO review.

Authors:  Michael A Vogelbaum; Daria Krivosheya; Hamid Borghei-Razavi; Nader Sanai; Michael Weller; Wolfgang Wick; Riccardo Soffietti; David A Reardon; Manish K Aghi; Evanthia Galanis; Patrick Y Wen; Martin van den Bent; Susan Chang
Journal:  Neuro Oncol       Date:  2020-11-26       Impact factor: 12.300

Review 2.  Current challenges for the early clinical development of anticancer drugs in the era of molecularly targeted agents.

Authors:  Christophe Le Tourneau; Véronique Diéras; Patricia Tresca; Wulfran Cacheux; Xavier Paoletti
Journal:  Target Oncol       Date:  2010-04-02       Impact factor: 4.493

3.  Synthesis and Antitumor Activity Evaluation of a Novel Combi-nitrosourea Prodrug: BGCNU.

Authors:  Yameng Wang; Ting Ren; Xinxin Lai; Guohui Sun; Lijiao Zhao; Na Zhang; Rugang Zhong
Journal:  ACS Med Chem Lett       Date:  2017-01-13       Impact factor: 4.345

4.  Dose finding for continuous and ordinal outcomes with a monotone objective function: a unified approach.

Authors:  Anastasia Ivanova; Se Hee Kim
Journal:  Biometrics       Date:  2008-05-13       Impact factor: 2.571

Review 5.  DNA repair dysregulation from cancer driver to therapeutic target.

Authors:  Nicola J Curtin
Journal:  Nat Rev Cancer       Date:  2012-12       Impact factor: 60.716

6.  Active and alkylated human AGT structures: a novel zinc site, inhibitor and extrahelical base binding.

Authors:  D S Daniels; C D Mol; A S Arvai; S Kanugula; A E Pegg; J A Tainer
Journal:  EMBO J       Date:  2000-04-03       Impact factor: 11.598

7.  Point mutations at multiple sites including highly conserved amino acids maintain activity, but render O6-alkylguanine-DNA alkyltransferase insensitive to O6-benzylguanine.

Authors:  M Xu-Welliver; A E Pegg
Journal:  Biochem J       Date:  2000-04-15       Impact factor: 3.857

8.  Radical surgery after chemotherapy: a new therapeutic strategy to envision in grade II glioma.

Authors:  Hugues Duffau; Luc Taillandier; Laurent Capelle
Journal:  J Neurooncol       Date:  2006-04-28       Impact factor: 4.130

9.  A Phase III study of radiation therapy (RT) and O⁶-benzylguanine + BCNU versus RT and BCNU alone and methylation status in newly diagnosed glioblastoma and gliosarcoma: Southwest Oncology Group (SWOG) study S0001.

Authors:  Deborah T Blumenthal; Cathryn Rankin; Keith J Stelzer; Alexander M Spence; Andrew E Sloan; Dennis F Moore; Gilbert D A Padula; Susan B Schulman; Mark L Wade; Elisabeth J Rushing
Journal:  Int J Clin Oncol       Date:  2014-11-19       Impact factor: 3.402

10.  Phase II trial of Gliadel plus O6-benzylguanine in adults with recurrent glioblastoma multiforme.

Authors:  Jennifer A Quinn; Sara Xiaoyin Jiang; James Carter; David A Reardon; Annick Desjardins; James J Vredenburgh; Jeremy N Rich; Sridharan Gururangan; Allan H Friedman; Darell D Bigner; John H Sampson; Roger E McLendon; James E Herndon; Stevie Threatt; Henry S Friedman
Journal:  Clin Cancer Res       Date:  2009-02-01       Impact factor: 12.531

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