Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer
This trial is active, not recruiting.
|Treatments||bcg vaccine, prostate cancer vaccine ony-p1, placebo|
|Sponsor||Kael-GemVax Co., Ltd.|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2007|
|End date||September 2012|
|Trial size||54 participants|
|Trial identifier||NCT00514072, CDR0000559937, NCI-07-C-0188, ONYVAX-ONY-P1-07-01|
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.
|Masking||double blind (subject, investigator)|
Time to PSA progression
Immunologic response as assessed by ELISPOT assay
PSA kinetics (doubling time/velocity) of treatment
Time to testosterone recovery
Male participants at least 18 years old.
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
|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|
|Principal investigator||James L. Gulley, MD, PhD, FACP|
|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.|
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