A phase I study of cisplatin, temozolomide and thalidomide in patients with malignant brain tumors

Fable Zustovich, Giuseppe Cartei, Renato Ceravolo, Stefania Zovato, Alessandro Della Puppa, Davide Pastorelli, Martina Mattiazzi, Roberta Bertorelle, Marina Paola Gardiman

Research output: Contribution to journalArticle

Abstract

Background: There is pre-clinical evidence of synergism between cisplatin (P) and temozolomide (T) due to higher inhibition by T of O6-alkyl- guanine-alkyltransferase (AGAT), an enzyme involved in the mismatch repair system. T and P are active against malignant gliomas while thalidomide (TH) is emerging as an inhibitor of angiogenesis. Patients and Methods: Triplets of patients with malignant brain tumors received escalating doses of P, T and TH up to the dose-limiting-toxicity (DLT) and the maximal tolerated dose (MTD). Results: Seventeen patients were enrolled and a total of 74 cycles were delivered. The MTD was P 75 mg/m2 day 1 and T 150 mg/m2 days 1 to 5 every 21 days with a concomitant 200 mg total daily dose of TH. DLT events were G4 thrombocytopenia and febrile neutropenia. Conclusion: Concomitant administration of P 75 mg/m2 day 1, T 150 mg/m2 days 1 to 5 every 21 days and concomitant TH at a total daily dose of 150 mg is feasible and safe. Early efficacy data are encouraging and a phase II study is ongoing.

Original languageEnglish
Pages (from-to)1019-1024
Number of pages6
JournalAnticancer Research
Volume27
Issue number2
Publication statusPublished - Mar 2007

Keywords

  • Brain
  • Chemotherapy
  • Cisplatin
  • Gliomas
  • Malignant
  • Temozolomide
  • Thalidomide
  • Tumors

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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  • Cite this

    Zustovich, F., Cartei, G., Ceravolo, R., Zovato, S., Della Puppa, A., Pastorelli, D., Mattiazzi, M., Bertorelle, R., & Gardiman, M. P. (2007). A phase I study of cisplatin, temozolomide and thalidomide in patients with malignant brain tumors. Anticancer Research, 27(2), 1019-1024.