Clinical trial NCT00514072: Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: Kael-GemVax Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-09
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to PSA progression
Secondary outcomes:
measure: Toxicity
measure: Immunologic response as assessed by ELISPOT assay
measure: PSA kinetics (doubling time/velocity) of treatment
measure: Time to testosterone recovery
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: James L. Gulley, MD, PhD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.