Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Biological: allogeneic tumor cell vaccine; Biological: therapeutic autologous dendritic cells

• Registration Number: NCT00814892
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-25
• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Results First Submitted: 2013-05-16
• Results First Submitted QC: 2013-07-26
• Results First Posted: 2013-08-29
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC-APCC	allogeneic tumor cell vaccine	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.
DC-APCC	therapeutic autologous dendritic cells	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Are Progression Free at One Year	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 Outcome Measures

Name	Time	Method
Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire	Baseline and cycle 1	European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline.; Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase.
Progression Free Survival (PFS)	Up to 3 years	PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.
Number of Participants With Severe Adverse Events	Every cycle during treatment (up to 14 cycles)	Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
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)	In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.; The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA.
Duration of PSA-based Response	Up to 3 years	PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later.; The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value.

Trial Locations

Locations (1)

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States