A Phase II Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Are Progression Free at One Year
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer.
PURPOSE: This phase II trial is studying how well the combination of a proven effective allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.
Detailed Description
OBJECTIVES: Primary * Determine the proportion of patients with androgen-independent prostate cancer who are progression-free at one year after treatment with DC-APCC. Secondary * Evaluate treatment toxicity. * Evaluate time to prostate-cancer specific mortality. * Evaluate progression-free survival. * Evaluate time to PSA progression, and duration of PSA-based response. * Evaluate quality of life of patients treated with this regimen. OUTLINE: Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation and will receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID in every 2 weeks for the first 2 treatments (cycle 1 and 2), and then every 4 weeks therafter for up to 14 administrations in the absence of disease progression or unacceptable toxicity. The first four patients will be observed for four weeks following the third DC-APCC vaccination to assess toxicity, the enrollment of patients will continue if toxicity related events not present. Patients undergo blood sample collection periodically for translational studies. Samples are measured for a number of immune parameters by quantifying T-cell and dentritic 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. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Who Are Progression Free at One Year
Time Frame: One year
Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
Secondary Outcomes
- Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire(Baseline and cycle 1)
- Progression Free Survival (PFS)(Up to 3 years)
- Number of Participants With Severe Adverse Events(Every cycle during treatment (up to 14 cycles))
- Time to Prostate-cancer Specific Mortality(Registration to Prostate-cancer specific mortality (Up to 3 years))
- Time to Prostate-specific Antigen (PSA) Progression(Registration to PSA progression (Up to 3 years))
- Duration of PSA-based Response(Up to 3 years)