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Abstract
Purpose—
To determine the maximum tolerated dose (MTD), toxicity spectrum, clinical activity, and biological effects of the tropism-modified infectivity-enhanced CRAd, Ad5-Δ24-RGD, in patients with gynecologic malignancies.
Experimental Design—Cohorts of eligible patients were treated daily for 3 days via intraperitoneal catheter. Vector doses ranged from 1×109 to 1×1012 viral particles/day. Toxicity was evaluated utilizing CTCv3.0. CA-125 and RECIST criteria were utilized to determine clinical efficacy. Corollary biologic studies included assessment of CRAd replication, wild type virus generation, viral shedding, and neutralizing antibody response.
Results—
Twenty-one patients were enrolled. Adverse clinical effects were limited to G1/2 fever, fatigue, or abdominal pain. No vector related grade 3/4 …