Clinical trial NCT00814892: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-25
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Are Progression Free at One Year
timeFrame: One year
Secondary outcomes:
measure: Number of Participants With Severe Adverse Events
timeFrame: Every cycle during treatment (up to 14 cycles)
measure: Time to Prostate-cancer Specific Mortality
timeFrame: Registration to Prostate-cancer specific mortality (Up to 3 years)
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Registration to PSA progression (Up to 3 years)
measure: Duration of PSA-based Response
timeFrame: Up to 3 years
measure: Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire
timeFrame: Baseline and cycle 1
measure: Progression Free Survival (PFS)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manish Kohli, MD
role: STUDY_CHAIR
References: