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A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation


OBJECTIVES:

Primary

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

Secondary

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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)

PRIOR CONCURRENT THERAPY:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to PSA progression

Safety Issue:

No

Principal Investigator

James L. Gulley, MD, PhD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000559937

NCT ID:

NCT00514072

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182