A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid
After initial diagnosis patients will be treated with a standard platinum/etoposide regimen.
This standard first-line chemotherapy may/will be administered to patients under the
direction of their primary medical oncologist inside or outside of the Moffitt Cancer
Center. Patients will receive the platinum drug on day 1 and etoposide on days 1-3 of each
21-day cycle for 4-6 cycles. Patients who have progressive disease at this point are changed
to second line chemotherapy, and will not be eligible to participate in this clinical trial.
Patients who achieve a complete response, partial response, or stable disease (CR, PR, or
SD) after standard first-line chemotherapy will be enrolled. Radiographic studies and tumor
measurements are repeated 3-6 weeks after the last dose of chemotherapy (+/- PCI) and may be
repeated after prophylactic cranial irradiation (PCI) at the discretion of the principal
investigator (PI) and treating physician.
PCI will be permitted at the discretion of the treating oncologist(s). The initial
radiation consultation and simulation should occur as soon as the final staging has
occurred. Ideally, treatment should commence 1-2 weeks after final staging has been
confirmed and will be administered in 10-15 fractions over a 2-3 week period, as recommended
by the treating radiation oncologist. Although steroid use is not prohibited, it is
recommended and preferred that they not be used during PCI (steroids will have to be
discontinued ≥ 2 weeks before first vaccination). PCI can also be considered between
vaccines #4 and #5 or vaccine #5 and #6 in those patients eligible for the second course of
vaccinations. Systemic dose of steroids will NOT be allowed in these cases unless strictly
necessary and after discussion with the PI.
Patients who achieve CR, PR or SD after the completion of first line chemotherapy +/- PCI
will be screened for initial registration. Screening tests and procedures will be performed
approximately 4-6 weeks after the completion of first line chemotherapy or 6-9 weeks after
completion of PCI. Ideally, screening should be completed 1-2 weeks prior to leukopheresis.
Patients who successfully complete the screening exams for initial registration will be
randomized into one of three study arms.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Tumor Response in Each Group
To evaluate the efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C. That is, to estimate the objective tumor response rate for each treatment group. Tumor response will be assessed via radiographic imaging which will occur after every 2 cycles of chemotherapy (paclitaxel). Tumor response will be defined as partial response (PR) or complete response (CR).
Scott Antonia, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
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