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Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
allogeneic tumor cell vaccine
therapeutic autologous dendritic cells
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonist, or another equivalent hormonal agent)

      • Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy)
  • Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer)
  • PSA 2.0-100.0 ng/mL
  • Serum testosterone < 50 ng/dL (unless undergoing antiandrogen monotherapy)
  • No concurrent evidence of radiological or new clinically palpable metastatic cancer

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 3,500/µL
  • Platelet count ≥ 100,000/µL
  • Hemoglobin ≥ 10.0 g/dL
  • Creatinine ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Fertile patients must use effective contraception
  • Willing to provide blood samples for research purposes
  • Able to complete questionnaire(s) alone or with assistance
  • Able to undergo leukapheresis
  • No known immunodeficiency
  • No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only
  • No concurrent serious illness
  • No known history of positive PPD skin test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy

  • More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents

    • Inhaled corticosteroids allowed
  • More than 1 month since prior and no concurrent estrogens and/or ketoconazole
  • More than 3 months since prior and no other concurrent investigational medicinal products
  • More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer
  • No prior prostate cancer vaccine
  • No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy
  • No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy

Sites / Locations

  • Mayo Clinic Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC-APCC

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Are Progression Free at 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

Number of Participants With Severe Adverse Events
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
Time to Prostate-specific Antigen (PSA) Progression
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
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.
Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire
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)
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.

Full Information

First Posted
December 24, 2008
Last Updated
October 8, 2013
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00814892
Brief Title
Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to funding issues.
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DC-APCC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
allogeneic tumor cell vaccine
Intervention Description
Given intradermally
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Description
Given intradermally
Primary Outcome Measure Information:
Title
Number of Participants Who Are Progression Free at One Year
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of Participants With Severe Adverse Events
Description
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 Frame
Every cycle during treatment (up to 14 cycles)
Title
Time to Prostate-cancer Specific Mortality
Time Frame
Registration to Prostate-cancer specific mortality (Up to 3 years)
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
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.
Time Frame
Registration to PSA progression (Up to 3 years)
Title
Duration of PSA-based Response
Description
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.
Time Frame
Up to 3 years
Title
Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire
Description
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.
Time Frame
Baseline and cycle 1
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonist, or another equivalent hormonal agent) Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy) Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer) PSA 2.0-100.0 ng/mL Serum testosterone < 50 ng/dL (unless undergoing antiandrogen monotherapy) No concurrent evidence of radiological or new clinically palpable metastatic cancer PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 12 weeks WBC ≥ 3,500/µL Platelet count ≥ 100,000/µL Hemoglobin ≥ 10.0 g/dL Creatinine ≤ 2.0 mg/dL Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) AST ≤ 2.5 times ULN Fertile patients must use effective contraception Willing to provide blood samples for research purposes Able to complete questionnaire(s) alone or with assistance Able to undergo leukapheresis No known immunodeficiency No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only No concurrent serious illness No known history of positive PPD skin test PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents Inhaled corticosteroids allowed More than 1 month since prior and no concurrent estrogens and/or ketoconazole More than 3 months since prior and no other concurrent investigational medicinal products More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer No prior prostate cancer vaccine No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Kohli, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

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