A Randomized Phase II Clinical Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With or Without Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma
- To compare the progression-free survival rate at 1 year in patients with
androgen-independent non-metastatic prostate cancer treated with allogeneic prostate
cancer cell vaccine (APCC) with vs without autologous myeloid dendritic cells.
- To compare the toxicities of these regimens in these patients.
- To compare the overall survival, progression-free survival, time to PSA progression,
and duration of PSA-based response in patients treated with these regimens.
- To compare the quality of life of patients treated with these regimens.
- To evaluate the ability of the novel dendritic cell-APCC vaccination strategies to
induce vaccine-specific immune response in these patients.
OUTLINE: Patients are stratified according to 2-year survival probability (< 30% vs ≥ 30%).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive allogeneic prostate cancer cell vaccine (APCC) intradermally
(ID) on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients undergo standard leukapheresis to harvest peripheral blood mononuclear
cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and
autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID
on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of
disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for translational studies. Samples are
measured for a number of immune parameters by quantifying T-cell and dendritic cell
populations by analysis of surface marker molecules by flow cytometry, T-cell proliferation
assay, non-specific cytokine release, lysate-specific cytokine release, and cytokine
expression measured by cytometric bead array and qPCR.
Patients complete quality-of-life questionnaires periodically.
After completion of study treatment, patients are followed periodically for up to 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 1 year as assessed by radiographic studies and PSA levels
Manish Kohli, MD
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|