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Clinical Trial
. 2013 Jan;71(1):183-91.
doi: 10.1007/s00280-012-1995-7. Epub 2012 Oct 12.

Oblimersen in combination with temozolomide and albumin-bound paclitaxel in patients with advanced melanoma: a phase I trial

Affiliations
Clinical Trial

Oblimersen in combination with temozolomide and albumin-bound paclitaxel in patients with advanced melanoma: a phase I trial

Patrick A Ott et al. Cancer Chemother Pharmacol. 2013 Jan.

Abstract

Purpose: The combination of oblimersen, a bcl-2 antisense oligonucleotide, and dacarbazine lead to superior progression-free survival in advanced melanoma patients VSports手机版. Albumin-bound paclitaxel (nab-paclitaxel) has single-agent activity in melanoma. .

Methods: In a phase I trial, chemotherapy-naïve patients with metastatic melanoma and normal LDH levels were enrolled on 3 cohorts. The treatment regimen consisted of 56-day cycles of oblimersen (7 mg/kg/day continuous IV infusion on day 1-7 and 22-28 in cohort 1 and 2; 900 mg fixed dose, twice weekly in weeks 1-2, 4-5 for cohort 3), temozolomide (75 mg/m(2), days 1-42), and nab-paclitaxel (175 mg/m(2) in cohort 1 and 3, 260 mg/m(2) in cohort 2 on day 7 and 28). Apoptosis markers were tested in pre- and post-treatment specimens of a subset of patients V体育安卓版. .

Results: Six grade 3 events (neutropenia, renal insufficiency, hyponatremia, elevated creatinine, allergic reaction, and neuropathy) and 2 grade 4 events (neutropenia and thrombocytopenia) were seen in 32 patients. The objective response rate was 40 V体育ios版. 6% (2 complete responses and 11 partial responses) and 11 patients had stable disease, for a disease control rate of 75%. .

Conclusions: The combination of oblimersen, temozolomide, and nab-paclitaxel was well tolerated and demonstrated encouraging activity in patients with advanced melanoma VSports最新版本. .

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