title: A pilot feasibility study of TNFerade™ biologic with capecitabine and radiation therapy followed by surgical resection for the treatment of rectal cancer.
abstract: OBJECTIVE
  The purpose of this pilot study was to evaluate the feasibility and tolerability of weekly intratumoral TNFerade™ injections combined with concurrent capecitabine and radiotherapy in the treatment of patients with locally advanced rectal cancer.
  
  
  METHODS
  Patients with T3, T4, or N+ rectal cancer received radiotherapy to a total dose of 50.4-54 Gy in combination with capecitabine 937.5 mg/m(2) p.o. b.i.d. TNFerade™ at a dose of 4 × 10(10) particle units was injected into the rectal tumor on the first day of radiotherapy and weekly for a total of 5 injections. Surgery was performed 5-10 weeks after the completion of chemoradiation.
  
  
  RESULTS
  Nine patients were enrolled in this pilot trial. The stage was cT2 in 2 patients, cT3 in 6 patients, cT4 in 1 patient, N- in 7 patients and N+ in 2 patients. Eight patients completed all treatments. Grade 3 hematologic toxicity was observed in 2 patients. There was no toxicity directly attributable to the injection procedure. A complete pathologic response was observed in 2 of 9 patients.
  
  
  CONCLUSIONS
  This study demonstrates the feasibility of weekly intratumoral TNFerade™ injections during chemoradiotherapy for locally advanced rectal cancer. Pathologic responses with this combination compare favorably to published rates.
authors: Section of Translational Radiation Oncology, Radiation Oncology Branch, Center for Cancer Research, NCI, NIH, Bethesda, MD 20892, USA. citrind@mail.nih.gov
authors: Deborah
authors: D
authors: Citrin
authors: Kevin
authors: K
authors: Camphausen
authors: Bradford J
authors: BJ
authors: Wood
authors: Martha
authors: M
authors: Quezado
authors: John
authors: J
authors: Denobile
authors: James F
authors: JF
authors: Pingpank
authors: Richard E
authors: RE
authors: Royal
authors: H Richard
authors: HR
authors: Alexander
authors: Geoffrey
authors: G
authors: Seidel
authors: Seth M
authors: SM
authors: Steinberg
authors: Yvonne
authors: Y
authors: Shuttack
authors: Steven K
authors: SK
authors: Libutti
mesh_terms: D000328:Adult; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015316:Genetic Therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010865:Pilot Projects; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D014409:Tumor Necrosis Factor-alpha / Q000235:genetics*
chemical_list: D014409:Tumor Necrosis Factor-alpha; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil