At a glance
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Phase 1/2, Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Ad/PNP and Fludarabine Phosphate for Recurrent Head and Neck Cancer. Completed, enrolled 10 participants across 3 sites.
Detailed Summary
Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study. Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP. FDA Office of Orphan Drugs Division is a source of funding for the overall project.
Study Details
Timeline
Interventions
Ad/PNP is a replication defective adenoviral vector expressing E. coli Purine Nucleoside Phosphorylase
Fludarabine phosphate is an anticancer agent currently used for treatment of patients with chronic lymphocytic leukemia.