Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer - Full Text View

Purpose

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 randomized phase II trial is studying two different types of vaccines to compare how well they work in treating patients with non-metastatic prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Biological: allogeneic tumor cell vaccine Biological: therapeutic autologous dendritic cells	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Progression-free survival rate at 1 year as assessed by radiographic studies and PSA levels [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity and tolerability as assessed by NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]
Time to PSA progression [ Designated as safety issue: No ]
Duration of PSA-based response [ Designated as safety issue: No ]
Quality of life as assessed by the EORTC QLQ-C30 questionnaire [ Designated as safety issue: No ]
Evolution of vaccine-specific immune response as a function of time and number of vaccine administrations [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Biological: allogeneic tumor cell vaccine Given intradermally
Experimental: 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.	Biological: allogeneic tumor cell vaccine Given intradermally Biological: therapeutic autologous dendritic cells Given intradermally

Arms

Assigned Interventions

Experimental: 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.

Biological: allogeneic tumor cell vaccine

Given intradermally

Experimental: 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.

Biological: allogeneic tumor cell vaccine

Given intradermally

Biological: therapeutic autologous dendritic cells

Given intradermally

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814892

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Manish Kohli, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Trials Office, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00814892 History of Changes
Other Study ID Numbers:	MC0554, MC0554, 06-004659
Study First Received:	December 24, 2008
Last Updated:	November 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

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

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013