| Inclusion Criteria: | Signed informed consent.
Pt must be ineligible for resection.
Head & Neck disease accessible to intra-tumoral injections. Can remain elig if inaccessible but longest diameter is </= 1.5cm & location does not predictably increase pt's morbidity or mortality.
Absence of CNS metastasis.
Age >/= 18. Pts must use adequate birth control and notify PI should a preg occur for self or partner.
Karnofsky Performance Status >/= 60% at screening.
Labs: ANC>/=2x10(9)/L, platelets>/=80x10(9)/L; total bilirubin, AST/SGOT & ALT/SGPT</=2.0xULN, alkaline phosphatase</=3xULN, serum creatinine </= ULN or creatinine clearance>/=50ml/min.
Neg serology for HIV 1 & HIV 2, Hepatitis B surface antigen & Hepatitis C antibody.
Adequate tumor tissue must be made available to determine p53 mutation status by DNA sequencing.
Pt must not be in contact with former tissue or organ transplant recipients & persons known suffering from severe immunodeficiency disease either during treatment or within 28 days after last dose of RPR/INGN 201.
Histologically confirmed squamous cell carcinoma (SCC) of the head and neck i.e., oral cavity, oropharyx, larynx or hypopharynx, nasal cavity, paranasal sinuses or primary keratinizing SCC of the nasopharynx.
Pt.must have local/regional recurrent disease following prim.therapy or prog. disease druing prim.therapy. Recurrent disease must be confirmed by cytology/histology. There may be any # of prior recurrences,provided all elig.crit. are met.
Pts. must have been treated with a minimum of standard method radiation (5,000 cGy).
Pts. must have failed at least one chemotherapy regimen containing either a platinum or taxane.
Pts.must have at least 1 lesion in head&neck region that's bidimenstionally meas. by rad. scan (CT,MRI or US) or physical exam; limited to max. cum. sixe of less than or equal to 7.5cm defined by sum of longest diam. of each lesion to be injected. |