Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

Kael-GemVax

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: BCG vaccine; Biological: prostate cancer vaccine ONY-P1; Other: placebo

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00514072

NCI-07-C-0188

ONYVAX-ONY-P1-07-01

CDR0000559937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

54 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

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.

Treatment:

Biological: BCG vaccine

Biological: prostate cancer vaccine ONY-P1

Arm II

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo