SWOG clinical trial number
S0011
Phase II 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
Closed
Phase
Accrual
22%
Published
Abbreviated Title
Squamous cell carcinoma
Activated
03/01/2003
Closed
07/01/2006
Participants
Limited: Institutions Listed on the Title Page
Research committees
Head and Neck Cancer
Treatment
Cisplatin
Radiation Therapy
Surgery
INGN 201
Eligibility Criteria Expand/Collapse
Pts must have high risk/limited Stage III or IV squamous cell ca of the oral cavity, oropharynx, hypopharynx, or larynx that is newly dx, previously untreated, histologically proven with no evidence of distant metastases. Pts dz must be considered srg resectable. Pts must have evidence of regional lymph node met (N1-N3). A CXR must be obtained w/in 28 days prior to reg. Dz staging must be done w/in 28 days of reg by either one or more of the following: clinical exam, CT, MRI, and/or endoscopy.
Pts must have adequate renal, hepatic function and adequate hematologic values. Pts must have neg serology for HIV and must have serum mg less than or equal to ILN obtained w/i 28 days prior to reg. Adequate sections from original diag speciments must be available for path review.
Instutional Biosafety Committee (IBC) and Institutional Review Board (IRB) approval must be received AND submitted to the Southwest Oncology Group Operations Office prior to reg first pt.
Pts must have adequate renal, hepatic function and adequate hematologic values. Pts must have neg serology for HIV and must have serum mg less than or equal to ILN obtained w/i 28 days prior to reg. Adequate sections from original diag speciments must be available for path review.
Instutional Biosafety Committee (IBC) and Institutional Review Board (IRB) approval must be received AND submitted to the Southwest Oncology Group Operations Office prior to reg first pt.
Publication Information Expand/Collapse
2009
A phase II 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: report of the Southwest Oncology Group [PMID19770418; PMC3098124]