A Pilot Study of Autologous Tumor DRibble Vaccine With Docetaxel in Stage IIIB and IV Non-Small Cell Lung Cancer
Ten patients will be enrolled. Study treatment is as follows: Docetaxel 75 mg/m2 will be
given on day 1. Intradermal vaccinations of DRibbles from 5-20 x 106 cell equivalents per
vaccine will begin 14 days after docetaxel. Immediately following vaccination, subcutaneous
infusion of GM-CSF (50 micrograms/24 hrs) will be initiated. GM-CSF will be infused into
the vaccination site for 6 days using the CADD-MS 3 pump.
A second docetaxel injection will be given at day 29 followed by a second vaccination 14
days later and 3 additional vaccines will be given at 2-week intervals. Following each
vaccination, GM-CSF will again be infused over 6 days via the CADD-MS 3 pump.
Peripheral blood will be obtained for immune monitoring at each vaccination. DTH to
autologous tumor and to DRibble vaccine will be tested before the first and fifth vaccines.
A second leukapheresis for immune monitoring will be obtained at 12 weeks. Clinical tumor
response will be assessed after the fifth vaccination unless clinical evidence of tumor
progression occurs sooner.
Immune response will be assessed by DTH, T-cell function, T-cell migration into the vaccine
sites and cytokine release assays. Sophisticated flow cytometry assays will be used to
detect active T-cell subsets. Safety will be monitored by physical and laboratory exams at
each vaccine visit and adverse events will be recorded and reported as appropriate.
Clinical response will be assessed by tumor measurements by CT scan and/or physical exam at
study entry and after 12 weeks. PFS and OS will be recorded.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Vaccine-induced immune response as measured by in vitro immune monitoring and by the delayed-type hypersensitivity (DTH) testing to injections of autologous, unmodified tumor cells and to DRibbles.
DTH on days 7-10 and days 77-80 and blood for immune monitoring (30-50 cc) prior to each vaccine.
Walter J Urba, MD, PhD
Providence Health & Services
United States: Food and Drug Administration
|Providence Portland Medical Center||Portland, Oregon 97213-3635|