Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Sponsor

Kael-GemVax Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00514072

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

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

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Masking:

Double (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

Study Start Date :

Mar 1, 2007

Anticipated Primary Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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