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- Title
A phase II study of ispinesib (SB-715992) in patients with metastatic or recurrent malignant melanoma: a National Cancer Institute of Canada Clinical Trials Group trial.
- Authors
Christopher Lee; Karl Bélanger; Sanjay Rao; Teresa Petrella; Richard Tozer; Lori Wood; Kerry Savage; Elizabeth Eisenhauer; Timothy Synold; Nancy Wainman; Lesley Seymour
- Abstract
<div class="Abstract"><a name="Abs1"></a><span class="AbstractHeading">Summary </span>To assess the response rate and toxicity of the kinesin spindle protein (KSP) inhibitor, ispinesib, in malignant melanoma. Seventeen patients were enrolled from April to November 2005. Ispinesib was administered as a 1-hour infusion at a dose of 18 mg/m2 once every 3 weeks until disease progression. No objective responses were seen. Six patients (35%) had a best response of stable disease for a median duration of 2.8 months. Disease progression was documented in 9 (53%) after 1 or 2 cycles. Eighty-eight percent of patients received ≥90% of planned dose intensity. Grade 3 non-hematologic toxicities included dizziness (1) and blurred vision (1). There was one episode of febrile neutropenia, but no grade 3 or 4 biochemical adverse events. Pharmacokinetics was consistent with prior studies. KSP immunoreactivity was seen in 14 of 16 available archival tissue samples (88%). Ispinesib can be safely administered using the dose and schedule employed, with mild hematologic and non-hematologic toxicity. No objective responses were observed, and further development of single-agent ispinesib in malignant melanoma is not recommended. Although KSP expression appears to be common in melanoma, KSP may not be a suitable target for its treatment. </div>
- Subjects
CANADA; MELANOMA; DRUG metabolism; FEBRILE neutropenia
- Publication
Investigational New Drugs, 2008, Vol 26, Issue 3, p249
- ISSN
0167-6997
- Publication type
Article
- DOI
10.1007/s10637-007-9097-9