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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, 09/22/09

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

Results

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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Spread of Squamous Cell Carcinoma From the Thumb to the Small Finger via the Flexor Tendon Sheaths
The Journal of Hand Surgery, 11/16/09 Relevance Score: 83%

Squamous cell cancer of the rectum
World Journal of Gastroenterology, 10/01/09 Relevance Score: 82%

Primary cutaneous myxoid spindle cell squamous cell carcinoma: a clinicopathologic study and review of the literature
Journal of Cutaneous Pathology, 10/09/09 Relevance Score: 81%

RalA suppresses early stages of Ras-induced squamous cell carcinoma progression
Oncogene, 10/08/09 Relevance Score: 81%

Nd:YAG laser therapy of carcinoma lip (stage I squamous cell carcinoma): a retrospective evaluation
Indian Journal of Otolaryngology and Head & Neck Surgery, 10/07/09 Relevance Score: 81%