Neoadjuvant Ipilimumab in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide Acetate; Ipilimumab; Radical Prostatectomy
Intervention description: 22.5 mg administered as a single intramuscular 3 month depot.; 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.; Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
Intervention MeSH terms: Ipilimumab; Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone Ablation; Prostate adenocarcinoma; Radical prostatectomy; Leuprolide Acetate; Lupron Depot; Ipilimumab; BMS-734016; MDX010

Summary:

      The goal of this clinical research study is to learn how ipilimumab in combination with
      Lupron (leuprolide acetate) affects the body's own defense (immune) system before having
      surgery to remove prostate cancer. The safety of the drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to give written informed consent;

          2. Histologic Documentation: Histologic documentation of prostatic adenocarcinoma.
             Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
             eligible. All eligible patients must have a known Gleason sum based on biopsy or TURP
             at the time of registration.

          3. Locally Resectable Disease: Patients must have disease (localized or locally advanced)
             which is deemed by the surgeon to be resectable. Lymph node metastasis or lymph nodes
             suspicious of harboring metastasis should be deemed surgically resectable by the
             surgeon.

          4. Determination of high-risk status: Patients must have either: 1) a Prostate biopsy
             Gleason sum >/= 8 OR 2) PSA >/= 20.

          5. Prior Treatment: No prior treatment for prostate cancer including prior surgery
             (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
             Patients who have initiated leuprolide acetate within 1 week of signing consent will
             be eligible.

          6. Patients must be appropriate candidates for radical prostatectomy. Evidence of
             underlying cardiac disease should be evaluated prior to enrollment to ensure that
             patients are not at high risk of cardiac complications.

          7. ECOG performance status of 0 or 1;

          8. Required values for initial laboratory tests: a) WBC >/= 3000/uL; b) ANC >/= 1500/uL,
             c) Platelets >/= 100 x 10^3/uL; d) Hemoglobin >/= 9 g/dL; e) Creatinine </= 2.0 x ULN;
             f) AST </= 2.5 x ULN; g) Bilirubin 0 - 1.0 mg/dL, except patients with Gilbert's
             Syndrome, who must have a total bilirubin less than 3.0 mg/mL;

          9. Men >/= 18 years of age

         10. Patients must agree to practice barrier birth control methods while on therapy, prior
             to surgery.

        Exclusion Criteria:

          1. Any other malignancy from which the patient has been disease-free for less than 5
             years, with the exception of adequately treated and cured basal or squamous cell skin
             cancer.

          2. Autoimmune disease: Patients with a history of Inflammatory Bowel Disease (including
             Crohn's disease and ulcerative colitis) are excluded from this study as are patients
             with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive
             sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g.,
             Wegener's Granulomatosis]).

          3. Known HIV or chronic hepatitis.

          4. Any underlying medical condition, which in the opinion of the Investigator, will make
             the administration of study drug hazardous or obscure the interpretation of adverse
             events, such as a condition associated with frequent diarrhea.

          5. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI
             obstruction, abdominal carcinomatosis which are known risks factors for bowel
             perforation, should be excluded from the study.

          6. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to
             one month prior to or after any dose of ipilimumab.

          7. Concomitant therapy with any of the following: IL-2, interferon or other non-study
             immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other
             investigation therapies; or chronic use of systemic corticosteroids (used in the
             management of cancer or non-cancer-related illnesses);

          8. Previous treatment with other investigational products within 30 days;

          9. Previous enrollment in another MDX-010 (BMS-734016) clinical trial or prior treatment
             with a CD137 agonist or CTLA-4 inhibitor or agonist

         10. Concurrent use of 5-alpha-reductase inhibitors (finasteride, dutasteride).

         11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious disease) illness must
             not be enrolled in this study.