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BNIT 1811   |   11-1163
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Disease(s)
Prostate
Hospital(s)
Main Campus
Phase(s)
Phase 3
Stage(s)
Type(s)
Therapeutic
Drug(s)
Leukine
PROSTVAC

Contact Information
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Description
Primary
  1. To ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).
Secondary
  1. To ascertain whether a greater proportion of patients randomized to Arm V+G or to Arm V remain event-free at six months as compared to the patients randomized to Arm P.

Inclusion Criteria
  1. Signed informed consent
  2. Men ≥ 18 years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
  3. Castrate testosterone level < 50 ng/dl
  4. Documented metastatic prostate cancer with progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
    • a. Radiological progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer. OR
    • b. PSA progression defined by sequence of rising values separated by greater than 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
  5. Chemotherapy naive. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate cancer is permissible if greater than 3 years prior.
  6. Vaccinia-experienced (previous smallpox vaccination)
  7. ECOG Performance Score of 0 or 1
  8. Life expectancy greater than or equal to 1 year
  9. Bone marrow function: absolute neutrophil count ≥ 1,500/mm^3, Hemoglobin ≥ 10 g/dL, Platelet count ≥ 100,000/mm^3
  10. Hepatic function: AST and ALT ≤ 2.5 times upper limit of normal (ULN), Bilirubin ≤ 1.5 times ULN
  11. Renal function: Creatinine ≤ 2.0 times ULN
  12. Currently using a GnRH agonist or antagonist (unless surgically castrated)

Exclusion Criteria
  1. Cancer-related pain requiring scheduled opioid narcotics for control (prn ≤ 2x per week is allowed)
  2. Metastasis to organ systems other than lymph nodes and/or bone
  3. LDH ≥ 2 times ULN
  4. Alkaline phosphatase ≥ 2 times ULN
  5. Estimated PSA doubling time of < 1 month as established within 6 months of the anticipated first dose of vaccine or placebo. A minimum of 3 PSA level determinations, at least 2 weeks apart (over a 6 month time-period), is required for assessment.
  6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer
  7. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC. There is no exclusion to previous experimental therapy provided dosing/treatment is completed at least 30 days prior to the first planned dose of vaccine unless otherwise noted (#5, #14 this section).
  8. History of prior malignancies other than prostate cancer within the past 3 years, excluding basal or squamous cell carcinoma of the skin
  9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
  10. Significant medical abnormality (defined as a pre-existing AE/condition ≥ Grade 2 according to NCI CTCAE v 4.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter (or Clinically Significant as defined by institutional normal ranges, but in the opinion of the Investigator, consistent with values seen for patients with mCRPC) may be eligible provided a written approval is granted by the study Medical Monitor prior to enrollment.
  11. Confirmed positive for HIV, hepatitis B, and /or hepatitis C
  12. Prior solid organ or bone marrow transplant
  13. Immunodeficiency or splenectomy
  14. Chronic immunosuppressive therapy within 30 days of screening
  15. Inflammatory eye disease requiring steroid treatment
  16. Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
  17. History of or active autoimmune disease. Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogrens syndrome, scleroderma, myasthenia gravis, Goodpastures syndrome, Addisons disease, Hashimotos thyroiditis, or Graves disease. Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
  18. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Patients with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the patients medical history and in the chart notes.
  19. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
  20. Previous adverse reactions to smallpox vaccination
  21. Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children ≤ 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
  22. Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
  23. Study personnel

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