Outcomes of patients with metastatic melanoma treated with molecularly targeted agents in phase I clinical trials

Montserrat Blanco Codesido, Andre Tesainer Brunetto, Sophia Frentzas, Victor Moreno Garcia, Dionysis Papadatos-Pastos, Joanna Vitfell Pedersen, Leonardo Trani, Martina Puglisi, L. Rhoda Molife, Udai Banerji

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5 Citations (Scopus)


Introduction: First-line treatment options utilizing chemotherapy and cytokine-based treatments for patients with metastatic melanoma (MM) are unsatisfactory. We analyzed the clinical outcomes of patients with MM treated in phase I trials of novel agents. We hypothesized that patients included in phase I clinical trials did not have worse outcomes than with the chemotherapy and cytokine-based first-line treatment. Methods: Data of patients with MM treated at The Drug Development Unit between 2004 and 2010 were collected. The response rate (RR) and time to progression (TTP) for first-line therapy were compared to those of phase I trial therapy. Patients acted as their own controls for statistical analyses. Results: Sixty-five patients were treated in 31 phase I trials. First-line treatment included dacarbazine or temozolomide in 58 (89%) cases and interferon-α in 5 patients (8%) and cisplatin-based treatment in 2 patients (3%). There was no significant difference in either the RR (11 vs. 14%, p = 0.87) or TTP (90 vs. 53 days, p = 0.15) in patients treated with first-line treatment versus phase I treatment, respectively. Conclusion: Phase I clinical trials of molecularly targeted agents show clinical activity that is not dissimilar to that of treatment with existing chemotherapy and cytokine-based treatment.

Original languageEnglish
Pages (from-to)135-140
Number of pages6
Issue number2
Publication statusPublished - 1 Oct 2011
Externally publishedYes


  • Clinical trial
  • Metastatic melanoma
  • Phase I
  • Treatment

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