A phase 2 trial of high-dose Allovectin-7 in patients with advanced metastatic melanoma.
7509 Background: A bicistronic plasmid encoding HLA-B7 and β-2 microglobulin genes formulated in cationic lipids, Allovectin-7® (A-7), is an immunotherapeutic designed to induce a pro-inflammatory response and express MHC-class I after tumor injections. Expression of HLA-B7 in tumors may result in increased immunorecognition of tumors that in turn elicits an antitumor response. METHODS: We are conducting a phase 2 trial to evaluate the activity of A-7 in patients (pts) with metastatic melanoma (MM). Eligible pts have stage III or IV MM recurrent or unresponsive to prior therapy; injectable (1 to 25 cm(2) cutaneous, subcutaneous, or nodal) lesion(s); ECOG PS 0-1 and adequate organ function. Pts with brain or non-lung visceral metastases or any lesion ≥ 100 cm(2) are excluded. Pts with 2 or more injectable lesions are randomized to receive injections into 1 or up to 5 lesions. Pts receive weekly intratumoral injections of a total of 2 mg for 6 wks followed by 3 wks of observation and evaluation. Response is assessed using RECIST guidelines two wks following the last injection of each cycle. Pts with stable or responding disease receive additional cycles. RESULTS: Interim unaudited data will be presented for all 133 pts enrolled. All pts were evaluated for safety (6 pts in the dose escalation stage plus 127 pts in the high-dose stage), and 127 pts are evaluated for efficacy. In an interim data analysis 12 of 91 pts (13.2%) achieved an objective response lasting a median duration of 6.4 months. Median overall survival has not yet been reached and durability of response is still accruing. One Grade 3 and no Grade 4 adverse event associated with A-7 have been reported. CONCLUSIONS: Interim results indicate that high-dose A-7 is an active, well-tolerated treatment for Stage III/IV MM pts with injectable cutaneous, subcutaneous, or nodal lesions. No significant financial relationships to disclose.
Richards, J; Bedikian, AY; Gonzalez, R; Atkins, MB; Whitman, ED; Lutzky, J; Morse, MA; Amatruda, T; Galanis, E; Vical Clinical Research Operations Team,
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