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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00970203
Other study ID # 06-070
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date October 5, 2019

Study information

Verified date October 2020
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the feasibility, safety, and efficacy of intradermal vaccination of prostate cancer patients with alpha-type-1-polarized dendritic cells (DC1) loaded with apoptotic allogeneic tumor (LNCap). The study will target men with recurrent prostate cancer, who failed local therapy, have no measurable metastasis, but have a rising PSA with a doubling time of less than 10 months. The selection of this study group enables us to evaluate time to PSA progression, a highly relevant, clinical primary endpoint of efficacy in this two arm study. In order to facilitate infiltration of vaccination-induced T cells into tumor site(s) and to reduce tumor-specific tolerance, subjects will receive the vaccine in combination with limited androgen ablation (AA) with a LHRH analogue for 3 months. Subjects will be randomly assigned to one of two cohorts. In cohort A subjects will be first treated with limited AA alone for 3 months, and at the time of PSA relapse (PSA ≥ 1 ng/dL) will receive the DC vaccine in conjunction with AA. In cohort B, the sequence of treatment will be reversed. Efficacy will be estimated as the within-subject difference in time to PSA relapse following the combination treatment as compared to the AA alone, thus, each subject will serve as his own control. All subjects will commence the DC1-based vaccination 2 weeks prior to treatment with the LHRH analogue. Each subject will receive 1 intradermal (i.d.) dose of the vaccine at weeks 1, 5, 9, and 13 for a total of 4 doses. Additional courses of vaccination may be administered to subjects without evidence of disease progression every 3 months (±1 month) for up to 12 months depending on the number of doses originally produced and available after the 4 intended protocol doses. All doses of the vaccine will be administered intradermally (i.d.).


Description:

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Study Design


Intervention

Biological:
androgen ablation (AA)
Lupron 22.5 mg or Zoladex 10.8 mg
DC1 vaccine
3-5 x 10e6 cells total

Locations

Country Name City State
United States University of Pittsburgh Cancer institute Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine The percentage of patients for which the alpha-DC1 vaccine was generated and for which 4 vaccine injections were administered (1 injection every 4 weeks). 16 weeks
Primary Tolerability and Toxicity of the Alpha-DC1 Vaccine The percentage of patients who experienced vaccine related toxicity. 16 weeks
Primary The Effect of the DC1 Vaccine on Time to PSA Progression Compared to AA Alone The mean difference between time to relapse on androgen ablation plus alpha DC-1 vaccine vs androgen ablation Approximately 18 months
Secondary Change in PSA Velocity Prior to and Following the Proposed Treatment. Approximately 18 months
Secondary Evaluate (in All Subjects) the Vaccination-induced DTH Responses to LNCap, the Cell Line Vaccine, and to Compare This With Vaccination-induced Responses to Tumor-untreated Antigen (KLH) Approximately 17 weeks
Secondary Evaluate the Vaccination-induced Changes of Th1/Th2 Profiles of the Responses to PAP and PSMA Approximately 18 to 24 months
Secondary Evaluate the CTL Responses in Blood to the Whole LNCap Cells (in All Subjects) and (in All Subjects Who Are HLA-A2 Positive) the CTL Responses to HLA-A2.1 Restricted Peptides Derived From PAP and PSMA Approximately 18 to 24 months
Secondary Comprehensively Evaluate the CD4+ and CD8+ T Cell Responses (Fine Specificity and Th1/Th2/Treg Cytokine Profile) to the Previously-identified and Novel Immunogenic Epitopes of PAP and PSMA, Using the EPIMAX System Approximately 18 to 24 months
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