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Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma.

Publication ,  Journal Article
Quinn, JA; Reardon, DA; Friedman, AH; Rich, JN; Sampson, JH; Vredenburgh, J; Gururangan, S; Provenzale, JM; Walker, A; Schweitzer, H; Allen, D ...
Published in: Neuro Oncol
April 2004

Irinotecan is a topoisomerase I inhibitor previously shown to be active in the treatment of malignant glioma. We now report the results of a phase 1 trial of irinotecan plus BCNU, or 1,3-bis(2-chloroethyl)-1-nitrosourea, for patients with recurrent or progressive MG. Irinotecan dose escalation occurred independently within 2 strata: patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) and patients not receiving EIAEDs. BCNU was administered at a dose of 100 mg/m2 over 1 h every 6 weeks on the same day as the first irinotecan dose was administered. Irinotecan was administered intravenously over 90 min once weekly. Treatment cycles consisted of 4 weekly administrations of irinotecan followed by a 2-week rest with dose escalation in cohorts of 3 to 6 patients. Seventy-three patients were treated, including 49 patients who were on EIAEDs and 24 who were not on EIAEDs. The maximum tolerated dose for patients not on EIAEDs was 125 mg/m2. The maximum tolerated dose for patients on EIAEDs was 225 mg/m2. Dose-limiting toxicity was evenly distributed among the following organ systems: pulmonary, gastrointestinal, cardiovascular, neurologic, infectious, and hematologic, without a clear predominance of toxicity involving any one organ system. There was no evidence of increasing incidence of toxicity involving one organ system as irinotecan dose was escalated. On the basis of these results, we conclude that the recommended doses of irinotecan for a phase 2 clinical trial when given in combination with BCNU (100 mg/m2) are 225 mg/m2 for patients on EIAEDs and 125 mg/m2 for patients not on EIAEDs.

Duke Scholars

Published In

Neuro Oncol

DOI

ISSN

1522-8517

Publication Date

April 2004

Volume

6

Issue

2

Start / End Page

145 / 153

Location

England

Related Subject Headings

  • Oncology & Carcinogenesis
  • Oligodendroglioma
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Irinotecan
  • Humans
  • Glioma
  • Glioblastoma
  • Female
 

Citation

APA
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MLA
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Quinn, J. A., Reardon, D. A., Friedman, A. H., Rich, J. N., Sampson, J. H., Vredenburgh, J., … Friedman, H. S. (2004). Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma. Neuro Oncol, 6(2), 145–153. https://doi.org/10.1215/S1152851703000498
Quinn, Jennifer A., David A. Reardon, Allan H. Friedman, Jeremy N. Rich, John H. Sampson, James Vredenburgh, Sridharan Gururangan, et al. “Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma.Neuro Oncol 6, no. 2 (April 2004): 145–53. https://doi.org/10.1215/S1152851703000498.
Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Vredenburgh J, et al. Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma. Neuro Oncol. 2004 Apr;6(2):145–53.
Quinn, Jennifer A., et al. “Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma.Neuro Oncol, vol. 6, no. 2, Apr. 2004, pp. 145–53. Pubmed, doi:10.1215/S1152851703000498.
Quinn JA, Reardon DA, Friedman AH, Rich JN, Sampson JH, Vredenburgh J, Gururangan S, Provenzale JM, Walker A, Schweitzer H, Bigner DD, Tourt-Uhlig S, Herndon JE, Affronti ML, Jackson S, Allen D, Ziegler K, Bohlin C, Lentz C, Friedman HS. Phase 1 trial of irinotecan plus BCNU in patients with progressive or recurrent malignant glioma. Neuro Oncol. 2004 Apr;6(2):145–153.
Journal cover image

Published In

Neuro Oncol

DOI

ISSN

1522-8517

Publication Date

April 2004

Volume

6

Issue

2

Start / End Page

145 / 153

Location

England

Related Subject Headings

  • Oncology & Carcinogenesis
  • Oligodendroglioma
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Irinotecan
  • Humans
  • Glioma
  • Glioblastoma
  • Female