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A phase 2 trial of surgery with perioperative INGN 201 (AD5CMV-P53) gene therapy followed by chemoradiotherapy for advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx
Archives of Otolaryngology, 09/29/09
Yoo GH et al. – This trial demonstrated the feasibility of handling and delivering a very complex gene vector safely in multiple cooperative group institutions without significant incident. Intraoperative INGN 201 gene therapy is technically feasible, but it has many logistical problems when performed in a multi-institutional setting. Regulatory requirements might have hindered accrual in this multi-institutional setting. Disease control seems to be promising; however, no definitive conclusion can be made with this small sample size.
Methods- Phase 2 study
- 13 individuals
- Newly diagnosed
- Previously untreated squamous cell carcinoma of the oral cavity oropharynx, larynx, or hypopharynx
- Selected stage III or IV disease without distant metastases; and surgically resectable disease
- 13 patients received surgery and perioperative INGN 201 injections in the primary tumor bed and the ipsilateral neck
- 3 patients did not receive chemoradiotherapy
- 1 patient had a grade 2 fistula of the oral cavity
- Of the 10 patients with evaluable data, 2 experienced grade 4 adverse events, 1 owing to hypokalemia, hyponatremia, vomiting, leukopenia, and neutropenia and 1 owing to increased aspartate aminotransferase and alanine aminotransferase levels
- 7 other patients experienced grade 3 adverse events
- Estimate of 1-year progression-free survival 92%
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