(ChemotherapyAdvisor) – A reovirus-based vaccine that sensitizes tumor cells to treatment with carboplatin and paclitaxel chemotherapy shrinks head and neck tumors, according to a recent study published in the April 1 issue of Clinical Cancer Research. The study, entitled “Phase 1/2 Trial of Carboplatin and Paclitaxel Chemotherapy in Combination with Intravenous Oncolytic Reovirus in Patients with Advanced Malignancies,” aimed to assess the efficacy and safety of reovirus type 3 Dearing (RT3D) combined with carboplatin and paclitaxel in patients with advanced cancers.
In this Phase 1/2 clinical trial, patients were initially treated with an escalating dose of intravenous RT3D on days one to five, and then carboplatin and paclitaxel three times weekly. The study aimed to meet two primary endpoints: 1) to define the maximum tolerated dose and dose-limiting toxicity and 2) to recommend a dose for Phase 2 studies, whereas the study’s secondary endpoints included pharmacokinetics, immune response, and antitumor activity. Phase 1 results identified an RT3D dose of 3×1010 TCID50, which was subsequently used to characterize the response rate in patients with head and neck cancer in Phase 2.
The authors reported dose-limiting toxicities during dose-escalation; and of the toxicities that were observed, most toxicities were grade 1/2. “Overall effectiveness rates were as follows: One patient had a complete response (3.8%), six patients (23.1%) had partial response, two patients (7.6%) had major clinical responses clinically evaluated in radiation pretreated lesions which are not evaluable by Response Evaluation Criteria in Solid Tumors (RECIST), nine patients (34.6%) had stable disease, and eight patients (30.8%) had disease progression,” the authors wrote.
The authors concluded: “The combination of RT3D plus carboplatin/paclitaxel is well tolerated with evidence of activity in cancer of the head and neck. A randomized Phase 3 study is currently open for recruitment.”