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Phase II trial of carmustine plus O-6-benzylguanine for patients with nitrosourea-resistant recurrent or progressive malignant glioma

  1. Author:
    Quinn, J. A.
    Pluda, J.
    Dolan, M. E.
    Delaney, S.
    Kaplan, R.
    Rich, J. N.
    Friedman, A. H.
    Reardon, D. A.
    Sampson, J. H.
    Colvin, O. M.
    Haglund, M. M.
    Pegg, A. E.
    Moschel, R. C.
    McLendon, R. E.
    Provenzale, J. M.
    Gururangan, S.
    Tourt-Uhlig, S.
    Herndon, J. E.
    Bigner, D. D.
    Friedman, H. S.

  2. Author Address

    Duke Univ, Med Ctr, Brain Tumor Ctr, Dept Surg, Box 3624, Durham, NC 27710 USA Duke Univ, Med Ctr, Brain Tumor Ctr, Dept Surg, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Pathol, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Radiol, Durham, NC 27710 USA Duke Univ, Med Ctr, Dept Biostat & Bioinformat, Durham, NC 27710 USA Univ Chicago, Dept Med, Chicago, IL 60637 USA Penn State Univ, Milton S Hershey Med Ctr, Dept Cellular & Mol Physiol & Pharmacol, Sch Med, Hershey, PA 17033 USA NCI, Frederick Canc Res & Dev Ctr, Chem Carcinogenesis Lab, Adv Biosci Labs, Frederick, MD USA NCI, Invest Drug Branch, NIH, Bethesda, MD 20892 USA Quinn JA Duke Univ, Med Ctr, Brain Tumor Ctr, Dept Surg, Box 3624, Durham, NC 27710 USA
    1. Year: 2002
  2. Journal: Journal of Clinical Oncology
    1. 20
    2. 9
    3. Pages: 2277-2283
  4. Type of Article: Article
  1. Abstract:

    Purpose : We conducted a phase 11 trial of carmustine (BCNU) plus the O-6-alkylguanine-DNA alkyltransferase inhibitor O-6- benzylguanine (O-6-BG) to define the activity and toxicity of this regimen in the treatment of adults with progressive or recurrent malignant glioma resistant to nitrosoureas. Patients and Methods: Patients were treated with O-6-BG at an intravenous dose of 120 m/m(2) followed 1 hour later by 40 mg/m(2) of BCNU, with cycles repeated at 6-week intervals. Results: Eighteen patients were treated (15 with glioblastoma multiforme, two with anaplastic astrocytoma, and one with malignant glioma). None of the 18 patients demonstrated a partial or complete response. Two patients exhibited stable disease for 12 weeks before their tumors progressed. Three patients demonstrated stable disease for 6, 12, and 18 weeks before discontinuing therapy because of hemaopoietic toxicity. Twelve patients experienced reversible greater than or equal to grade 3 hematopoietic toxicity. There was no difference in half-lives (0.56 +/- 0.21 hour v 0.54 +/- 0.20 hour) or area under the curve values (4.8 +/- 1.7 mug/mL/h v 5.0 +/- 1.3 mug/mL/h) of O-6-BG for patients receiving phenytoin and those not treated with this drug. Conclusion: These results indicate that O-6-BG plus BCNU at the dose schedule used in this trial is unsuccessful in producing tumor regression in patients with nitrosourea-resistant malignant glioma, although stable disease was seen in five patients for 6, 12, 12, 12, and 18 weeks. Future use of this approach will require strategies to minimize dose-limiting toxicity of BCNU such as regional delivery or hematopoietic stem-cell protection. (C) 2002 by American Society of Clinical Oncology.

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