A phase 2 trial of sequential temozolomide chemotherapy followed by high-dose interleukin 2 immunotherapy for metastatic melanoma

Cancer
Ahmad A TarhiniSanjiv S Agarwala

Abstract

Previous biochemotherapy regimens for metastatic melanoma have required attenuated dosages of interleukin 2 (IL-2) that may have compromised efficacy. In a phase 2 study, the authors tested sequential temozolomide (75 mg/m2 per day orally for 3 weeks) followed by high-dose, IL-2 (600,000 U/kg per dose intravenously; maximum, 14 doses over 5 days). Thirty-eight patients with treatment-naive American Joint Committee on Cancer stage IV melanoma (8 patients with M1a disease, 6 patients with M1b disease, and 24 patients with M1c disease) were enrolled. Ten patients had a history of treated brain metastases. Thirty-one patients who received at least 2 cycles of IL-2 were evaluable for response. Grade 3 toxicities included hyperbilirubinemia (9 patients), hematologic toxicities (leukopenia in 5 patients, thrombocytopenia in 3 patients), diarrhea (2 patients), and oliguria (1 patient). One patient had grade 4 nausea. The overall response rate (ORR) was 16% and included 3 complete responses that lasted 10.8 months, > or =32 months, and > or =36 months and 2 partial responses that lasted 13 months and 14 months. Responses were observed in patients with M1a disease and in patients with M1c disease. Sixteen patients had stable disease (15 ...Continue Reading

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Citations

Jun 8, 2010·Journal of Neurosurgery·Donald N LiewL Dade Lunsford
Feb 19, 2013·Immunotherapy·Marieke I G RaaijmakersMitchell P Levesque
May 20, 2009·Future Oncology·Aaron S Mansfield, Svetomir N Markovic
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Oct 31, 2015·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Zhengxiao OuyangGang Huang

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