Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ketoconazole; lenalidomide; therapeutic hydrocortisone
Intervention description: 400 tid; Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.; 20mg qam 10mg qhs
Intervention MeSH terms: Ketoconazole; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer

Summary:

      RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as
      ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the
      growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and
      hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer.

      PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone
      together with lenalidomide works in treating patients with prostate cancer that did not
      respond to hormone therapy.
    

Eligibility criteria:

        PATIENTS WITH PROSTATE CANCER PROGRESSIVE AFTER ANDROGEN DEPRIVATION Inclusion Criteria
        Understand and voluntarily sign an informed consent form. Age 18 years at the time of
        signing the informed consent form. Histologically confirmed adenocarcinoma of the prostate.
        Testosterone less than 50 ng/dL. Patients must continue primary androgen deprivation with
        an LHRH analogue if they have not undergone orchiectomy. All previous cancer therapy,
        including radiation, and surgery, must have been discontinued at least 4 weeks prior to
        receive first dose of study drug.

        Progressive disease after androgen deprivation.

        Exclusion Criteria Prior systemic chemotherapy for hormone refractory prostate cancer.
        Prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months
        prior to enrollment.

        Prior ketoconazole, aminoglutethimide or corticosteroids for the treatment of progressive
        prostate cancer.

        Prior immunotherapy including, but not limited to, vaccines, Thalidomide, and or
        Lenalidomide like agents.

        Supplements or complementary medicines/botanicals are not permitted while on protocol
        therapy, except for any combination of the following:

        conventional multivitamin supplements selenium lycopene soy supplements Patients should
        review the label with their doctor prior to enrollment, and discontinue disallowed agents
        prior to study enrollment Serious intercurrent infections or non-malignant medical
        illnesses including autoimmune disorders that are uncontrolled.

        Psychiatric illnesses/social situations that would limit compliance with protocol
        requirements.

        Evidence of CNS (brain or Leptomeningeal) metastases or large pleural/pericardial
        effusions.

        Known contraindication to receive Ketoconazole or Lenalidomide Concurrent use of
        ketoconazole with statin compounds is absolutely contraindicated. Thus, patients receiving
        Statin drugs (fluvastatin, atorvastatin, and simvastatin) should discontinue them for at
        least 7 days before starting ketoconazole.

        Patients taking astemizole, terfenadine, or cisapride, rifampin or isoniazid are not
        eligible, unless they agreed to completely discontinue those agents. In that case, any of
        these agents should be discontinued at least 7 days prior to start therapy with
        Ketoconazole.

        Use of any other experimental drug or therapy within 28 days of baseline. Known
        hypersensitivity to thalidomide or its analogues. Any prior use of Lenalidomide. Known
        positive for HIV or infectious hepatitis, type A, B or C. Disease free of prior
        malignancies for 5 years with exception of currently treated basal cell, squamous cell
        carcinoma of the skin, or carcinoma "insitu" of the breast.