Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00514072
• Other study ID #: CDR0000559937
• Secondary ID: NCI-07-C-0188ONY
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: August 8, 2012
• Start date: March 2007

Study information

• Verified date: August 2012
• Source: Kael-GemVax Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• BCG vaccine
given intradermally
• prostate cancer vaccine ONY-P1
given intradermally

Other:
• placebo
given intradermally

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Kael-GemVax Co., Ltd.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aragon-Ching JB, Williams KM, Gulley JL. Impact of androgen-deprivation therapy on the immune system: implications for combination therapy of prostate cancer. Front Biosci. 2007 Sep 1;12:4957-71. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to PSA progression			No
Secondary	Toxicity			Yes
Secondary	Immunologic response as assessed by ELISPOT assay			No
Secondary	PSA kinetics (doubling time/velocity) of treatment			No
Secondary	Time to testosterone recovery			No