Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

NCT ID: NCT00514072

Last Updated: 2012-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

BCG vaccine

Intervention Type: BIOLOGICAL

given intradermally

prostate cancer vaccine ONY-P1

Intervention Type: BIOLOGICAL

given intradermally

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

given intradermally

Interventions

BCG vaccine

given intradermally

Intervention Type: BIOLOGICAL

prostate cancer vaccine ONY-P1

given intradermally

Intervention Type: BIOLOGICAL

placebo

given intradermally

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Kael-GemVax Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James L. Gulley, MD, PhD, FACP

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.2741/2441.

Reference Type: BACKGROUND

PMID: 17569623 (View on PubMed)

Huang J, Jochems C, Talaie T, Anderson A, Jales A, Tsang KY, Madan RA, Gulley JL, Schlom J. Elevated serum soluble CD40 ligand in cancer patients may play an immunosuppressive role. Blood. 2012 Oct 11;120(15):3030-8. doi: 10.1182/blood-2012-05-427799. Epub 2012 Aug 28.

Reference Type: DERIVED

PMID: 22932804 (View on PubMed)

Other Identifiers

NCI-07-C-0188

Identifier Type: -

Identifier Source: secondary_id

ONYVAX-ONY-P1-07-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000559937

Identifier Type: -

Identifier Source: org_study_id