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Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Kael-GemVax Co., Ltd..
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kael-GemVax Co., Ltd. Identifier:
First received: August 8, 2007
Last updated: August 8, 2012
Last verified: August 2012

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.

Condition Intervention Phase
Prostate Cancer
Biological: BCG vaccine
Biological: prostate cancer vaccine ONY-P1
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation

Resource links provided by NLM:

Further study details as provided by Kael-GemVax Co., Ltd.:

Primary Outcome Measures:
  • Time to PSA progression

Secondary Outcome Measures:
  • Toxicity
  • Immunologic response as assessed by ELISPOT assay
  • PSA kinetics (doubling time/velocity) of treatment
  • Time to testosterone recovery

Estimated Enrollment: 54
Study Start Date: March 2007
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Biological: BCG vaccine
given intradermally
Biological: prostate cancer vaccine ONY-P1
given intradermally
Placebo Comparator: Arm II
Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Other: placebo
given intradermally

Detailed Description:



  • To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in patients with androgen-dependent stage D0 prostate cancer.


  • To evaluate all toxicities related to ONY-P1 vaccine.
  • To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo.
  • To evaluate PSA kinetics (doubling time/velocity) of treatment.
  • To evaluate time to testosterone recovery following limited androgen ablation.

OUTLINE: Patients are stratified according to estimated PSA doubling time (< 12 months vs ≥ 12 months).

Patients receive goserelin subcutaneously once. Approximately 3 months later, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for up to 15 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histopathological documentation of prostate cancer

    • If no pathologic specimen is available, patients may enroll on study with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease
  • Biochemical progression, as defined by the following:

    • A rise in PSA of ≥ 2 ng/mL above the nadir (for patients previously treated with definitive radiotherapy or cryotherapy)
    • Two consecutive rises in PSA > 0.3 ng/mL (for patients previously treated with radical prostatectomy)
  • PSA ≤ 20 ng/mL
  • Testosterone ≥ lower limit of normal
  • Negative CT scan and bone scan for metastatic prostate cancer
  • No clinically active brain metastases


  • ECOG performance status of 0-1
  • Life expectancy ≥ 6 months
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.5 mg/dL OR total bilirubin ≤ 3.0 mg/dL (in patients with Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times upper limit of normal
  • No other active malignancies within the past 60 months (with the exception of nonmelanoma skin cancer or carcinoma in situ of the bladder)
  • No life-threatening illnesses
  • No immunocompromised status due to any of the following:

    • HIV positivity
    • Active autoimmune diseases, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjögren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease

      • Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function, including CNS, heart, lungs, kidneys, skin, or gastrointestinal tract, will be allowed
    • Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs
  • No other serious medical illness that would interfere with the patient's ability to carry out the treatment program
  • No documented contraindication (allergy or severe reaction to BCG)


  • See Disease Characteristics
  • Recovered from all prior therapy, including surgery and radiotherapy (no toxicity ≥ grade 2)
  • No prior chemotherapy
  • No concurrent topical steroids (including steroid eye drops) or systemic steroids

    • Nasal or inhaled steroid use is permitted
  • No concurrent medications used for urinary symptoms, including 5-alpha reductase inhibitors (finasteride and dutasteride)
  • No concurrent alternative medications known to alter PSA (e.g., phytoestrogens or saw palmetto)
  • No other concurrent hormonal therapy
  • No other concurrent anticancer treatment, including chemotherapy, systemic glucocorticoids, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00514072

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Kael-GemVax Co., Ltd.
National Cancer Institute (NCI)
Principal Investigator: James L. Gulley, MD, PhD, FACP National Cancer Institute (NCI)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kael-GemVax Co., Ltd. Identifier: NCT00514072     History of Changes
Other Study ID Numbers: CDR0000559937
Study First Received: August 8, 2007
Last Updated: August 8, 2012

Keywords provided by Kael-GemVax Co., Ltd.:
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on April 25, 2017