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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Inclusion 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/mm³

- Platelet count ≥ 100,000/mm³

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 1 year as assessed by radiographic studies and PSA levels

Safety Issue:

No

Principal Investigator

Manish Kohli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC0554

NCT ID:

NCT00814892

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • 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
  • Prostatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905