title: Phase II trial of Belagenpumatucel-L, a TGF-beta2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients.
abstract: In a previous dose escalation trial we demonstrated dose related survival correlation to Belagenpumatucel-L. In order to further evaluate safety and response at the previously defined optimal dose and schedule and to gain preliminary evidence on a hypothesis that the level of circulating tumor cells (CTCs) in blood may correlate with the overall survival of patients with stage IV NSCLC, we initiated a phase II trial. Patients received intradermal immunization of 2.5 x 10(7) transfected allogeneic tumor cells (Belagenpumatucel-L, supplied by NovaRx) 1 x every month for a total of 16 months. Circulating tumor cells (Veridex, Raritan, NJ) were measured every 4 weeks. Twenty-one advanced NSCLC patients were enrolled on this study. No significant toxic effect was observed. Overall survival was 562 days. The median survival was 660 days in patients having less than 2 CTCs at baseline compared to 150 days in patients with 2 or more CTCs (P=0.025). Phase II results of safety and response are consistent with prior experience following treatment with Belagenpumatucel-L and there is a suggestion that the number of circulating tumor cells at baseline appears to correlate with overall survival. A larger clinical trial is warranted to further explore this observation.
authors.affiliation: Mary Crowley Cancer Research Centers, Dallas, TX 75201, USA. jnemunaitis@marycrowley.org
authors.forename: J
authors.initials: J
authors.lastname: Nemunaitis
authors.forename: M
authors.initials: M
authors.lastname: Nemunaitis
authors.forename: N
authors.initials: N
authors.lastname: Senzer
authors.forename: P
authors.initials: P
authors.lastname: Snitz
authors.forename: C
authors.initials: C
authors.lastname: Bedell
authors.forename: P
authors.initials: P
authors.lastname: Kumar
authors.forename: B
authors.initials: B
authors.lastname: Pappen
authors.forename: P B
authors.initials: PB
authors.lastname: Maples
authors.forename: D
authors.initials: D
authors.lastname: Shawler
authors.forename: H
authors.initials: H
authors.lastname: Fakhrai
mesh_terms: D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D016373:DNA, Antisense / Q000096:biosynthesis; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D015316:Genetic Therapy / Q000379:methods; D006801:Humans; D007271:Injections, Intradermal; D008175:Lung Neoplasms / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D053781:Transforming Growth Factor beta2 / Q000037:antagonists & inhibitors* / Q000235:genetics; D014407:Tumor Cells, Cultured
chemical_list: D019496:Cancer Vaccines; D016373:DNA, Antisense; D053781:Transforming Growth Factor beta2; C514428:belagenpumatucel L